Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable... User manual

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DIAMONDBACK 360®Peripheral Orbital Atherectomy
System Exchangeable Series
Including the Orbital Atherectomy Device, Handle, Orbital
Atherectomy Cartridge, Saline Pump, VIPERWIRE ADVANCE®
Peripheral Atherectomy Guide Wire, and VIPERWIRE
ADVANCE®with FLEXTIP Peripheral Atherectomy Guide Wire
Instructions for use
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Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
The following are trademarks of Cardiovascular Systems, Inc.:
CSI®, Cardiovascular Systems®, DIAMONDBACK 360®, VIPERWIRE®, VIPERWIRE
ADVANCE®, VIPERWIRE ADVANCE®with FLEXTIP, VIPERSLIDE®, GlideAssist®

Explanation of Symbols on Package Labels
Refer to the package labels to see which symbols apply to specific products.
Lot number
Model number
Consult IFU www.csi360.com (USA) (Symbol appears in blue when
placed on the device itself)
Caution: Consult IFU www.csi360.com (USA)
Do not reuse.
Do not re-sterilize
Sterilized with Ethylene Oxide
Manufacturer
Use by
Maximum guide wire tip diameter
Maximum guide wire shaft diameter
Guide wire length
Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.
Contains phthalates

Explanation of Symbols on the Saline Pump
Low saline red LED indicator
Start button and pump ON green LED indicator
Pump status yellow LED indicator
Prime button
Type CF Applied Part
Slow Blow Type T Fuse

Explanation of Symbols on the Handle
Prime button
Low speed button
Medium speed button
High speed button
Rotate Symbol
Eject Symbol
Non-continuous use; spin cycles of 30 seconds on, 30
seconds off with maximum spin time of ≤ 8 minutes per
cartridge using no more than three cartridges per handle

Table of Contents
1. System Description................................................................................................1
2. System and Component Descriptions ...................................................................1
3. Indications for Use.................................................................................................9
4. Contraindications...................................................................................................9
5. Restrictions..........................................................................................................10
6. Warnings.............................................................................................................10
7. Precautions .........................................................................................................11
8. Storage and Handling..........................................................................................13
9. Adverse events....................................................................................................13
10. Clinical Trials Summary.......................................................................................14
11. Equipment, Setup, and Test................................................................................14
12. OAS Directions for Use .......................................................................................22
13.Specifications......................................................................................................32
14. OAS Pump Declaration of Conformity.................................................................34
15. EMC Declaration .................................................................................................34
16. FCC.....................................................................................................................37
17. Disclaimer of Warranty........................................................................................37
Appendix A. System Troubleshooting ...........................................................................39
Appendix B. Introducer, Guide Sheath, or Guide Catheter Size....................................44
Appendix C. Maximum Orbit and Resulting Lumen Diameter.......................................46
Appendix D. Orbit Performance ....................................................................................48

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1. System Description
The Cardiovascular Systems, Inc. (CSI) DIAMONDBACK 360 Peripheral Orbital Atherectomy
System (OAS) Exchangeable Series is a minimally invasive, catheter-based OAS designed for
improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by
the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may
lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. This system
treats a broad range of plaque types in the lower limbs and reduces or removes occlusive
material by using a spinning, orbiting diamond-coated crown, within peripheral arteries, in order
to restore lumen patency.
The OAS consists of a hand-held CSI DIAMONDBACK 360 Orbital Atherectomy Device (OAD),
the CSI Saline Pump (OAS pump), the CSI VIPERWIRE ADVANCE Peripheral Atherectomy
Guide Wire (guide wire) or CSI VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy
Guide Wire (guide wire), and the CSI VIPERSLIDE Lubricant (lubricant).
The Exchangeable Series allows for multiple treatment options by offering a variety of
cartridges, with different crown sizes, for use with a single handle. The Exchangeable Series
OAS cartridges are intended to provide variable crown sizes during a procedure. The cartridges
should be utilized for the treatment of multiple lesions to achieve full-leg revascularization. The
following Exchangeable Series package options are available:
•OAD - handle, cartridge, and saline line
•Handle-only with a saline line
•Cartridge-only
2. System and Component Descriptions
2.1. Orbital Atherectomy Device (OAD) Description
The OAD is a hand-held, over-the-wire device consisting of a handle, a cartridge, and a
saline line (Figure 1). The cartridge includes a sheath-covered drive shaft and a
diamond-coated crown. The diamond coating on the crown provides an abrasive surface
with which to reduce or remove occlusive material within peripheral arteries. The handle
includes control buttons for operating the OAD and contains the motor and electronics
that power the rotation of the drive shaft. The GlideAssist feature facilitates advancing
and retracting the OAD crown over the guide wire.
Warning: The device is designed to track and spin only over the CSI Peripheral
VIPERWIRE ADVANCE Guide Wire or the VIPERWIRE ADVANCE with FLEXTIP Guide
Wire. Do not use any other guide wire with this device.
Select a crown size according to the crown’s ability to cross the lesion within the minimum
proximal reference vessel diameter at the treatment site. See Table 1, Table 2, and
Table 3 for available crown sizes. See Appendices C and D for orbit performance.

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Table 1: Micro Crowns
Model Number
Type
Crown Size
Shaft
Length
Nose
Length*
DBP-EX-125MIC145
DBP-CART-125MIC145
OAD
Cartridge
1.25 mm
145 cm
7 mm
DBP-EX-125MIC75
DBP-CART-125MIC75
OAD
Cartridge
1.25 mm
75 cm
7 mm
*Nose length is the length of the drive shaft from the crown to the distal tip of the shaft.
Table 2: Solid Crowns
Model Number
Type
Crown Size
Shaft Length
Nose Length*
DBP-EX-125SOL75
DBP-CART-125SOL75
OAD
Cartridge
1.25 mm
75 cm
7 mm
DBP-EX-125SOL145
DBP-CART-125SOL145
OAD
Cartridge
1.25 mm
145 cm
7 mm
DBP-EX-150SOL145
DBP-CART-150SOL145
OAD
Cartridge
1.50 mm
145 cm
10 mm
DBP-EX-200SOL145
DBP-CART-200SOL145
OAD
Cartridge
2.00 mm
145 cm
30 mm
DBP-EX-125SOL200
DBP-CART-125SOL200
OAD
Cartridge
1.25 mm
200 cm**
10 mm
DBP-EX-150SOL200
DBP-CART-150SOL200
OAD
Cartridge
1.50 mm
200 cm**
10 mm
DBP-EX-175SOL180
DBP-CART-175SOL180
OAD
Cartridge
1.75 mm
180 cm**
30 mm
*Nose length is the length of the drive shaft from the crown to the distal tip of the shaft.
**180 cm and 200 cm length devices are intended to accommodate patient anatomy and physician
preferred access methodology, for example radial access. See Section 10.3 Initiating the Atherectomy
Procedure.
Table 3: Classic Crowns
Model Number
Type
Crown Size
Shaft
Length
Nose
Length*
DBP-EX-150CLA145
DBP-CART-150CLA145
OAD
Cartridge
1.50 mm
145 cm
15 mm
DBP-EX-200CLA145
DBP-CART-200CLA145
OAD
Cartridge
2.00 mm
145 cm
20 mm
*Nose length is the length of the drive shaft from the crown to the distal tip of the shaft.

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Figure 1. OAD - includes the handle, cartridge, and saline line
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Cartridge
A. Nose length
B. Crown
C. Saline sheath
D. Rotation grips
E. Saline line port connector
Handle
F. Crown advancer knob
G. On/Off button
H. Cartridge eject button
I. Speed buttons and indicators
J. Brake light indicator
K. Prime button
L. Guide wire brake lever
M. Electrical power cord
Saline line
N. Saline line port connector
O. Injection port
P. Saline tubing positioners
Q. Saline tubing

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R. Saline bag spike
OAD Features:
•On/Off Button to control when the crown starts and stops
•3 speed control buttons with LED indicators to select the crown rotation speed
•Saline prime button
•15 cm crown advancement with travel measurement indicators
•Ability to lock crown advancer knob to maintain crown position relative to handle
•Manual guide wire brake to restrict both the rotational and axial movement of the
guide wire with a LED indicator
•Eccentrically-mounted, diamond-coated crown that provides an abrasive surface with
which to reduce or remove occlusive tissue
•GlideAssist to facilitate advancing and retracting the OAD crown over the VIPERWIRE
guide wire.
•Ability to separate the cartridge from the handle to allow the use of multiple cartridges
in one case
•Crown advancement measurement indicators
•Able to load guidewire through proximal end of OAD

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2.2. Package Contents: OAD, Handle, Or Cartridge
2.2.1. OAD
The OAD and accessories are supplied sterile and are for single-use only. Each
package contains:
•OAD (fully assembled –one handle and one cartridge)
•Saline line (connects the OAD to the OAS pump)
2.2.2. Handle
The handle and accessories are supplied sterile and are for single-use only. Each
package contains:
•One handle
•Saline line (connects the OAD to the OAS pump)
2.2.3. Cartridge
The cartridge is supplied sterile and is for single-use only. Each package contains:
•One cartridge
2.3. OAS Pump Description
The OAS pump provides the saline pumping mechanism and power to the device. The
small, reusable, and portable OAS pump attaches to a standard five-wheel rolling
intravenous (IV) pole (Figure 2) and plugs in to a wall power outlet. The OAS pump
includes a built-in, audible 25 second spin time notification, system power and priming
buttons, and status indicators.

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Figure 2. OAS Pump
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A. IV pole screw clamp
B. IV pole (not included)
C. Low saline level sensor and connector cord
D. Control panel
E. OAS Pump door
F. OAD connection
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2.4. OAS Pump Package Contents
The OAS pump and accessories are supplied non-sterile. Each package contains:
•OAS Pump with attached IV pole screw clamp
•Power cord
•Low saline level sensor and connector cord
2.5. VIPERWIRE ADVANCE Peripheral Guide Wire Description
The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque
distal spring tip (Figure 3). The guide wire allows for proper positioning of the OAD crown
within peripheral arteries and provides a center of rotation for the OAD drive shaft. The
guide wire torquer is a small, plastic accessory, packaged with the guide wire, and
provides a gripping surface for manipulating the guide wire, if desired. Guide wires are
available in a variety of spring tip diameters (Tables 4 and 5).

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Figure 3. Guide wire
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A. Distal spring tip
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Table 4 VIPERWIRE ADVANCE Peripheral 0.014” Guide Wires
OAD Device
Shaft Length
Compatibility
Model Number
Guide wire
Spring Tip
Diameter
Guide
wire
Length
75 and 145 cm
VPR-GW-14
0.014”
335 cm
75 and 145 cm
VPR-GW-17
0.017”
335 cm
180 and 200 cm
VPR-GW-EL14
0.014”
475 cm
180 and 200 cm
VPR-GW-EL18
0.018”
475 cm
Table 5 VIPERWIRE ADVANCE with FLEXTIP Peripheral 0.014”Guide Wire
OAD Device
Shaft Length
Compatibility
Model Number
Guide wire
Spring Tip
Diameter
Guide
wire
Length
75 and 145 cm
VPR-GW-FT14
0.014”
335 cm
75 and 145 cm
VPR-GW-FT18
0.018”
335 cm
75 and 145 cm
VPR-GW-FLEX14
0.014”
335 cm
75 and 145 cm
VPR-GW-FLEX18
0.018”
335 cm
180 and 200 cm
VPR-GW-ELFLEX14
0.014”
475 cm
180 and 200 cm
VPR-GW-ELFLEX18
0.018”
475 cm

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2.6. VIPERWIRE ADVANCE Peripheral Guide Wire Package Contents
The guide wire and guide wire torquer are packaged separately from the OAD, are
supplied sterile and are for single-use only. Each VIPERWIRE ADVANCE package
contains:
•Five (5) guide wires
•Five (5) torquers
2.7. Lubricant Description
VIPERSLIDE Lubricant reduces friction between the OAD drive shaft and the guide wire.
It is packaged separately from the OAD.
Note: Please refer to the VIPERSLIDE Lubricant IFU prior to starting the atherectomy
procedure.
3. Indications for Use
The DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series is a
percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive
atherosclerotic disease in peripheral arteries and who are acceptable candidates for
percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV
shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in
patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous
transluminal angioplasty.
4. Contraindications
Use of the OAS is contraindicated in the following situations:
•The guide wire cannot be passed across the peripheral lesion.
•The system cannot be used in coronary arteries.
•The target lesion is within a bypass graft or stent.
•The patient has angiographic evidence of thrombus; thrombolytic therapy must be
instituted prior to atherectomy.
•The patient has angiographic evidence of significant dissection at the treatment site. The
patient may be treated conservatively to permit the dissection to heal before treating the
lesion with the OAS.

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5. Restrictions
The OAS should only be used by physicians who are experienced in peripheral angioplasty at
their institutions and trained on the use of the OAS. Contact a CSI representative for information
on training.
6. Warnings
•Do not use the OAD in a vessel that is too small for the crown. The reference vessel
diameter at the treatment area must be at least 2.00 mm in diameter for the 1.25mm micro
crown.
•If mechanical failure of the OAD occurs before or during the atherectomy procedure,
discontinue use immediately. Do not attempt to use a damaged OAD or other system
component. Use of damaged components may result in system malfunction or patient injury.
•Do not use the OAD during spasm of the vessel.
•Only use the approved CSI VIPERWIRE ADVANCE 0.014-inch (0.3556 mm) × 335-cm
guide wires for 75cm and 145 cm length CSI crown and shaft configurations. Only use the
approved CSI VIPERWIRE ADVANCE 0.014-inch (0.3556 mm) x 475 cm guide wires for
180 cm and 200 cm length CSI crown and shaft configurations. See Table 4 and Table 5 for
the appropriate guide wire to use based on the OAD shaft configuration. Follow CSI’s
instructions related to guide wire use.
•Do not continue treatment if the guide wire or the OAD becomes sub-intimal.
•Immediately stop use if the OAD stalls. Review for complications and mechanical failure if a
stall condition occurs. Do not change to a higher speed if the OAD stalls.
Note: If a stall occurs, the On/Off button is inactive for five seconds. If the On/Off
button is pressed during this five second lockout period, the lockout period will begin
again.
•Performing treatment in vessels or bifurcations that are excessively tortuous or angulated
may result in vessel damage.
•Always use fluoroscopy when advancing the guide wire to avoid misplacement, dissection,
or perforation. The OAD tracks over the guide wire, so it is imperative that the guide wire be
initially placed through the stenotic lumen and not in a false channel.
•Do not inject contrast while OAD crown is spinning. OAD failure or patient harm may occur.
•Handle the OAD and guide wire carefully. A tight loop, kink, or bend in the guide wire may
cause damage and system malfunction during use.
•Never operate the OAD without normal saline and lubricant solution. Flowing saline and
lubricant solution is required for cooling and lubricating the OAD during use to avoid
overheating and permanent damage to the OAD and possible patient injury.
•The crown at the distal tip of the OAD operates at very high speeds. Do not allow body parts
or clothing to come into contact with the crown. Physical injury or entanglement may occur.
•Never advance the orbiting crown to the point of contact with the guide wire spring tip. Distal
detachment and embolization of the tip may result.

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•Always advance the orbiting, abrasive crown by using the crown advancer knob. Never
advance the orbiting crown by advancing the shaft or handle. Guide wire buckling may
occur, and perforation or vascular trauma may result.
•Always keep the crown advancing or retracting while it is at high rotational speeds. Do not
allow the crown to remain in one location for more than 2–3 seconds. Maintaining the crown
in one location while it is orbiting at high speeds may lead to excessive tissue removal.
•Do not start or stop orbiting of the crown when tight in a lesion.
•Never force the crown when rotational or translational resistance occurs; vessel perforation
may occur. If resistance to motion is noted, retract the crown and stop treatment
immediately. Use fluoroscopy to analyze the situation.
•When treating chronic total occlusion (CTO), create a channel at low or medium speed
before traversing the lesion at high speed. Crossing the CTO on high speed may cause the
shaft and/or guide wire to fracture as a result of excessive force.
•While advancing the crown through the introducer sheath/guide catheter, do not activate
crown rotation. The crown must not spin while located within the introducer sheath/guide
catheter.
•The maximum travel of the crown advancer knob—and therefore the shaft tip—is 15 cm.
Moving the crown advancer knob forward moves the shaft tip an equal distance toward the
guide wire spring tip. When moving the crown advancer knob, make sure there is sufficient
distance between the guide wire spring tip and the distal end of the shaft (10 cm minimum).
If the distance between the shaft tip and the guide wire spring tip is insufficient, the shaft tip
may damage the guide wire spring tip and result in dislodgement of the guide wire spring tip.
Use contrast injections and fluoroscopy to monitor movement of the shaft tip in relation to
the guide wire spring tip.
•Do not prolapse or bend the guide wire core. If the spring tip becomes prolapsed, keep the
bend/prolapse contained within the spring tip section only. A prolapsed or bent guide wire
core can result in damage to the guide wire or OAD.
•The system should not be used on children or pregnant women.
•Do not re-use or re-sterilize the OAD. If the OAD is re-used, the OAD may not function as
intended and serious infection, leading to potential harm and/or death, may occur.
•Do not spin the crown in GlideAssist, with the guide wire brake lever in the unlocked
position, without first securing the guide wire by holding it with fingers or by using the guide
wire torquer. If using the guide wire torquer, ensure that it is securely fastened to the guide
wire before starting to spin the crown. Failure to secure the guide wire when the brake is
unlocked could allow the guide wire to spin while in GlideAssist mode which may result in
patient harm.
7. Precautions
•If the sterile packaging appears damaged or shelf life has expired, do not use the product.
•Do not flip contents of trays into the sterile field as damage may occur. Components within
trays must be carefully removed and placed into sterile field to avoid damage.

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•Follow standard hospital atherectomy policies and procedures, including those related to
anticoagulation and vasodilator therapy.
•Radiographic equipment for fluoroscopy should be used to provide high-resolution images.
Guide wires and catheters should only be manipulated under fluoroscopy.
•Because of the torque responsiveness of CSI-approved guide wires, they are more difficult
to handle than other commercially available guide wires used in peripheral angioplasty.
Exercise care when using these guide wires.
•Use only normal saline and lubricant solution as the infusate. (Drugs such as vasodilators are
added to the infusate at the physician’s discretion). The OAD may malfunction if contrast or
other substances are injected into the OAD infusion port.
•Do not operate the OAD without recommended lubricants at the manufacturers’ recommended
concentration. Maximum speeds may not be achieved without lubricants.
•Ensure the OAD strain relief remains straight during atherectomy treatment.
•To relieve compression in the driveshaft, lock the crown advancer knob at 1cm from the full
back position, advance device over the wire to a position proximal from the lesion, deploy
the guide wire brake, then unlock the crown advancer knob and move it fully proximal. If the
OAD is started with existing compression in the driveshaft, it may result in the crown
springing forward.
•If 1:1 motion is not observed between the crown advancer knob and the crown, retract and
re-advance the crown into the lesion. Repeat retracting and advancing the crown into the
lesion until 1:1 movement is observed. If the knob and the crown are not moving together,
the crown may be driven into the lesion with too much force and may result in the crown
springing forward on exiting the lesion.
•When moving the eccentric diamond-coated crown back and forth across the lesion, employ
a series of intermittent treatment intervals and rest periods.
•Rest periods are recommended after 30-second treatment intervals, with a maximum total
treatment time of 8 minutes per cartridge.
•Monitor the saline fluid level during the procedure. Normal saline and lubricant solution
infusion is critical to OAD performance.
□Do not kink or crush the saline tubing. Flow of saline will be reduced.
□Check the saline tubing and connections for leaks during the procedure.
•Do not allow fluid to leak onto electrical connections of the OAS pump.
•Do not detach the cartridge from the handle when the OAD is over the guide wire. Kinking
of the guide wire and/or not being able to reconnect the cartridge and the handle may occur.
•Do not track only the cartridge into the patient and then attempt to connect the handle.
Kinking of the guide wire and/or not being able to reconnect the cartridge and the handle
may occur.
•Do not attempt to load a guide wire with a crossing profile >0.014” through the proximal end
of the OAD. Guide wire with a crossing profile >0.014” will not fit through the internal
components of the OAD.
•Do not attempt to remove the cartridge from the handle when spinning.

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8. Storage and Handling
8.1. Storage
Store all system components at room temperature and in a clean environment away
from magnets and sources of electromagnetic interference (EMI).
Do not store ViperSlide Lubricant above 25°C (77°F). Do not freeze ViperSlide
Lubricant. Refer to the ViperSlide Lubricant IFU prior to starting the atherectomy
procedure.
8.2. Handling
•All system and Exchangeable Series components are intended to be used in typical
operating room/catheterization laboratory environments.
•Additional components should be on hand in the event of damage to any of the
components or to component packaging.
•Do not reuse or resterilize the OAD, handle, cartridge, guide wire, guide wire torquer,
or lubricant as these components are designed for single-use only.
•Do not use the OAD, handle, cartridge, or the guide wire if their sterile package
barriers are compromised or damaged.
•Do not resterilize any component after exposure of the component to body tissue or
body fluids.
•Do not use the OAD, handle, cartridge, or OAS pump if any of them were dropped
onto a hard surface, from a height at or greater than 12 in (30 cm), as these
components may be damaged and may fail to operate properly.
•Do not use any system components after their use-by date.
•Do not use Viperslide Lubricant if it is exposed to temperatures outside the range
indicated on the package labels.
9. Adverse events
Potential adverse events that may occur and/or require intervention include, but are not limited
to:
•Allergic reaction to medication/media/OAD components
•Amputation
•Anemia
•Aneurysm

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•Bleeding complications which may require transfusion
•Cerebrovascular accident (CVA)
•Death
•Distal embolization
•Entry site complications
•Hemolysis
•Hypotension/hypertension
•Infection
•Myocardial infarction
•Pain
•Pseudoaneurysm
•Restenosis of treated segment that may require revascularization
•Renal insufficiency/failure
•Slow flow or no reflow phenomenon
•Thrombus
•Vessel closure, abrupt
•Vessel injury, including dissection and perforation that may require surgical repair
•Vessel spasm
•Vessel occlusion
10. Clinical Trials Summary
See www.CSI360.com for clinical trial information
11. Equipment, Setup, and Test
11.1. Equipment
In addition to the OAS components, equip the operating room with the following:
•Introducer, guide sheath, or guide catheter - see Appendix B for sizing
recommendations
•Standard IV pole with five wheels and a 20 inch diameter base
•1000 mL bag of normal saline
•Fluoroscopic imaging equipment
•Standard hospital grade, electrical wall outlet
•Other equipment, as needed, for interventional procedures
11.2. OAS Pump Set Up
1. Use the IV pole screw clamp to attach the OAS pump to a standard IV pole making
sure to attach the OAS pump to the IV pole at a distance not greater than 60 in (153
cm) from the floor to the top edge of the OAS pump.

15
2. Hang the low saline level sensor and cord, by the closed loop, from the horizontal
arm of the standard IV pole.
3. Plug the low saline level sensor connector into the back of the OAS pump (Figure ).
Figure 4. Plug in the low saline level sensor_________________
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4. Verify that the power cord is connected to the back of the OAS pump.
5. Insert the other end of the power cord into the electrical wall outlet.
Warning: To avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Warning: Ensure the power cord connection to the OAS pump and the on/off switch is
accessible at all times.
Caution: Do not allow fluid to leak onto electrical connections of the OAS pump.
11.3. Preparing the Bag of Saline and Lubricant
Ensure that the OAS pump is powered off by pressing the Master Power switch on
the back of the OAS pump to off and ensure that no LEDs are illuminated on the OAS
pump control panel (