Vascular Insights CLARIVEIN IC User manual

CLARIVEIN®IC, INFUSION CATHETER
WARNING
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your company representative. Inspect prior to use to verify that
no damage has occurred during shipping.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device failure,
which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization
may also create a risk of contamination of the device and/or cause patient infection or cross-
infection, including, but not limited to, the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy.
DEVICE DESCRIPTION
The ClariVein®IC is a specialty infusion catheter with 360˚ Rotatable Dispersion Wire connected
to a proximally located integral battery powered Motor Drive Unit (MDU). The MDU includes
the Speed Selector, handle grip and Syringe Locking Support features to facilitate physician-
controlled infusion of the selected agent. The ClariVein®IC is introduced through a
microintroducer. Utilizing vascular imaging, the coaxial Catheter Sheath with Dispersion Wire is
navigated through the vasculature to the treatment site. Fluid delivered through the Catheter
Assembly’s Check Valve and Injection Port surrounds the Dispersion Wire and exits via an
opening at the distal end of the catheter. The ClariVein®IC has no user serviceable parts or
capital equipment. It is fully disposable.
CONTENTS
1ClariVein®IC
1 Syringe 5 mL
INDICATIONS FOR USE
The ClariVein®IC is indicated for infusion of physician-specified agents in the peripheral
vasculature.
INTENDED USE
The ClariVein®IC is intended for the infusion of physician-specified agents in the peripheral
vasculature.
____________________________________________________________________
ClariVein®is a registered trademark of Vascular Insights™, LLC in the United States.
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CONTRAINDICATIONS
The ClariVein®IC is not intended for use in the following:
•Coronary and cerebral vasculature
•Pulmonary vasculature
•Diseased and atherosclerotic arteries
•Infusion of blood and blood products
WARNINGS
•This product should be used by physicians that have a thorough understanding of
intravascular ultrasound, angiography, peripheral vascular procedures and anatomy.
•Prior to use, carefully examine the ClariVein®IC and package contents included with
ClariVein® IC and verify they have not been damaged during shipment. If the components
show any sign of damage DO NOT USE.
•After use, dispose of the product per institutional protocol.
•Due to the risk of exposure to HIV or other blood borne pathogens, health care workers should
always use standard blood and body fluid precautions in the care of all patients. Sterile
techniques should be strictly adhered to during any handling of the device.
•Do not modify the device. To do so could result in injury, illness, or death.
CAUTIONS
•Do not use the ClariVein®IC in patients contraindicated for endovascular procedures.
•Do not use without completely reading and understanding the instructions for use.
NOTE: Packaging contents contains no medications. Prior to use, carefully read and
understand the respective manufacturer’s instructions for procedural accessory devices and
solutions intended for use including warnings, cautions, potential side effects and
contraindications.
•Before using ClariVein®IC, verify proper function and integrity of the device.
•Refer to package label for expiry date and do not use after expiration.
•Rotation of the ClariVein®IC Dispersion Wire is internally powered via a 9V DC battery. Prior
to use of the device, remove the Battery Terminal Insulator Tab by pulling tab away from
device.
•The integral 9V, DC battery is not intended to be either removed or replaced.
•Do not use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous
oxide in order to reduce any potential of static discharge or other ignition hazards.
•Select an appropriately sized vascular access device.
•Failure to use a compatible access device may result in damage to the device or cause patient
injury.
•Confirm syringe and Check Valve connections. Do not use if a leak persists.
•Manipulate the catheter in the vessel only under vascular imaging.
•Do not exert excessive force when withdrawing or advancing catheter. If resistance is
encountered, determine if remedial action is necessary. Failure to do so may result in device
damage or patient injury.
•Utilize vascular imaging such as ultrasound to confirm that the catheter tip is in the desired
location before activation of Dispersion Wire rotation.
____________________________________________________________________
ClariVein®is a registered trademark of Vascular Insights™, LLC in the United States.
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•When mating the MDU onto the Catheter Assembly Cartridge, do not bend or kink the
Dispersion Wire. To do so could cause damage to the device or patient injury.
•Slowly withdraw the device through the treatment area after Dispersion Wire activation. A
draw rate of approximately 1-2 mm/second is recommended while simultaneously infusing
fluid.
•Potential fatigue failure of the ClariVein®IC Dispersion Wire may occur with prolonged
activation of the device, which could result in device breakage.
•Prior to the Dispersion Wire rotation activation, confirm that the Catheter Assembly Cartridge
is securely mated in Position 2 in the MDU to avoid damage to the device and/or patient injury.
•Do not advance the Catheter Assembly when the Catheter Assembly Cartridge is mated to the
MDU and is in Position 2.
•Upon completion of the infusion procedure, prior to removal of the ClariVein®IC, move the
Catheter Assembly Cartridge to Position 1 in the MDU to avoid damage to the device and/or
patient injury.
•The Catheter Assembly and Motor Drive Unit cannot be separated after the Catheter Assembly
is moved to Position 2.
ADVERSE EVENTS
Potential adverse events that might be encountered during a peripheral vasculature infusion
procedure using the ClariVein® IC are similar to those associated with any interventional
procedure and include, but are not limited to, the following:
1. Abrupt thrombosis and occlusion of the treated vessel
8. Embolization
2. Bleeding from the site of access
9. Reaction to infused substances
3. Vascular rupture and perforation
10. Pain
4. Vascular dissection
11. Pseudoaneurysm
5. Hemolysis
12. Hypotension, Hypertension
6. Hematoma
13. Infection at the access site
7. Neurological deficits including stroke
14. Death
HOW SUPPLIED
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your Vascular Insights™representative. Do not use if labeling
is incomplete or illegible.
Handling and Storage
Store in cool, dry place.
DISPOSAL INSTRUCTIONS
After use, dispose of the products used in the procedure per institutional protocol.
Please note that the ClariVein®MDU unit contains a 9V DC battery, which is not intended for
removal.As such, the entire product, including the MDU is considered an infected medical
device and is fully disposable as medical/biohazard waste and is not intended to be included in
used electronic equipment recycling programs.
____________________________________________________________________
ClariVein®is a registered trademark of Vascular Insights™, LLC in the United States.
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OPERATIONAL INSTRUCTIONS
Procedural Accessory Devices and Agents
Prior to use, carefully read and understand the respective manufacturer’s instructions for
procedural accessory devices and solutions intended for use including warnings, cautions,
potential side effects and contraindications.
Patient Preparation
1. Use sterile technique per institutional protocol.
2. Medicate patient as appropriate.
3. Prepare and drape the puncture site.
4. Select an appropriately sized access device to accommodate the ClariVein®IC.
Recommended access device should be equal to or greater than a 4F introducer or 18G
Short Peripheral Catheter.
5. Administer local anesthetic at puncture site as needed per institutional protocol.
6. Prepare and place the access device per manufacturer’s instructions.
Device Preparation
1. Inspect the product package prior to opening. Do not use if package is opened or
damaged.
2. Use sterile technique to carefully remove the tray from the pouch and the contents from
the tray.
3. Inspect the device to be certain there are no visible signs of damage. Do not use if
contents are damaged.
4. Remove Battery Terminal Insulator Tab from the MDU and discard. (Figure 2, Item 12)
5. Confirm that the MDU has power by engaging the trigger (Figure 2, Item 10) and
confirming the Green Indicator Light is illuminated. (Figure 2, Item 13)
NOTE: The Dispersion Wire will not rotate if Green Indicator Light does not illuminate.
6. To attach the Check Valve turn clockwise onto the Catheter Assembly injection port.
(Figure 1, Item 2; Figure 3, Item 14)
7. Flush normal saline (USP 0.9%) through the Check Valve and Catheter Injection Port to
confirm a secure connection and patent catheter. (Figure 1, Item 2)
Caution: If leak is detected, reconfirm syringe and Check Valve connections. Do not use
if a leak persists.
8. Fill the 5 mL syringe with agent to be infused. (Figure 3, Item 15)
____________________________________________________________________
ClariVein®is a registered trademark of Vascular Insights™, LLC in the United States.
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Figure 1: Catheter Assembly
1. Cartridge 4. Catheter Sheath
2. Injection Port 5. Rotatable Dispersion Wire
3. Guide Wing 6. Dispersion Wire Tip
Figure 2: Motor Drive Unit
7. Mating Alignment Channel 11. Mating Alignment Channel
Position 1 Position 2
8. Speed Selector 12. Battery Terminal Insulator Tab
9. Syringe Locking Support 13. Green Indicator Light
10. Trigger
____________________________________________________________________
ClariVein®is a registered trademark of Vascular Insights™, LLC in the United States.
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