Abbott AMPLATZER TorqVue LP User manual

™
Instructions for Use
TorqVue
™
LP Catheter

Caution, consult accompanying documents
Not made with natural rubber latex
Inner diameter
Outer diameter
Length
Usable length
Recommended delivery sheath dimensions
Do not use if package is damaged
Manufacturer
Catalog number
Serial number
Caution: Federal law (USA) restricts this device to
sale by or on the order of a physician.
Batch Code
Use-by date

Date of manufacture
Do not reuse
Sterilized using ethylene oxide
Unique device identification
Quantity
Follow instructions for use on this website
Keep dry
Catheter
Contains phthalate
Do not resterilize

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AMPLATZER™TorqVue™LP Catheter
Device Description
The AMPLATZER™To r q Vu e ™LP Catheter is designed to provide a pathway through which
devices are introduced into the chambers and coronary vasculature of the heart or into the
peripheral vasculature. The body of the delivery catheter is radiopaque for visibility under
fluoroscopy.
A
B
C
D
Figure 1. AMPLATZER™TorqVue™LP Catheter components
A. Catheter
B. Tuohy-Borst hemostasis valve
C. Loader
D. Self-sealing hemostasis valve
Table 1. AMPLATZER™TorqVue™LP Catheter dimensions
Fr
mm (in) mm (in) cm
9-TVLPC4F90/080 41.17 (0.046) 1.40 (0.055) 80
Indications and Usage
The AMPLATZER™To r q V u e™LP Catheter is intended to provide a pathway through which
devices are introduced within the chambers and coronary vasculature of the heart or in the
peripheral vasculature.
Contraindications
None known.
Warnings
• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or
resterilize this device. Attempts to resterilize this device can cause a malfunction,
insufficient sterilization, or harm to the patient.
• Do not use this device if the sterile package is open or damaged.

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• Use the hemostasis valves to impede the back-flow of blood during the implant procedure
and minimize the risk of air ingress.
• Do not use a power injection syringe to inject contrast solution.
Precautions
• This device should be used only by physicians who are trained in standard transcatheter
techniques. The physician should determine which patients are candidates for procedures
that use this device.
• The physician should exercise clinical judgment in situations that involve the use of
anticoagulants or anti-platelet drugs before, during, and/or after the use of this delivery
catheter.
• Use on or before the last day of the expiration month that is printed on the product
packaging label.
• Use caution and rely on imaging guidance when advancing the sheath and dilator to avoid
damaging tissue and vessels or interfering with previously implanted medical devices.
• Store in a dry place.
Adverse Events
Potential adverse events that may occur during or after a procedure using this device may
include, but are not limited to:
• Air embolism
•Arrhythmia
• Arteriovenous fistulae
• Bleeding at the access site
• Brachial plexus injury
• Cardiac tamponade
•Death
• Dissection
•Embolism
• Endocarditis
• Hematoma
• Hemodynamic compromise
• Infection
• Myocardial infarction
• Perforation
• Peripheral pulse loss
• Stroke/transient ischemic attack
• Thrombosis
• Valve damage
• Vascular access site injury
• Vascular occlusion
• Vessel damage
Device Compatibility
Refer to the instructions for use supplied with the device to be implanted to determine catheter
compatibility.
Procedures
1. Prepare the delivery catheter for use:
- Inspect the delivery catheter sterile pouch and verify that it is unopened and
undamaged. Do not use the delivery catheter if the sterile barrier has been
compromised.
- Gently open the sterile pouch and inspect the components for damage. Do not use
damaged or kinked components.
- Flush all components with sterile saline.
- Wipe the delivery catheter with sterile gauze moistened with sterile saline to remove
any foreign material.
2. Connect the Tuohy-Borst hemostasis valve to the delivery catheter. Make sure there
are no gaps between the components.

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3. Flush the assembly with sterile saline.
4. Access the desired vessel.
5. Place a guidewire into the vasculature according to the device’s instructions for use
(0.014 to 0.035-in [0.36 to 0.89-mm]).
6. Advance the prepared delivery catheter over the guidewire until the delivery catheter is
positioned according to the device’s instructions for use.
7. Remove the guidewire. Allow back-bleeding to purge any air from the delivery catheter.
8. Flush the loader assembly (loader + self-sealing hemostasis valve) with heparinized
saline.
9. Capture the device to be implanted in the loader assembly according to the device's
instructions for use.
10. Insert the distal end of the loader into the proximal end of the Tuohy-Borst hemostasis
valve and advance into the delivery catheter until it stops. Tighten the hemostasis valve
to lock the components together and remove any air that may have entered the
delivery catheter system by aspirating and flushing with heparinized saline.
11. Hold the delivery catheter, Tuohy-Borst hemostasis valve, and loader assembly as a
unit. Move the device to be implanted from the loader into the catheter.
CAUTION: Move the device to be implanted carefully to prevent damage to the vessels
or cardiac tissue.
Note: If it is difficult to transfer the device to be implanted into the catheter, recapture
the device in the loader and adjust the position of the loader.
12. Deploy the device to be implanted according to the instructions for use supplied with
the device.
13. When the procedure is completed, remove the delivery wire and the catheter.
WARNING: Slowly remove the delivery catheter from the patient to prevent the
introduction of air.
Disposal
• The instructions for use are recyclable. Dispose of all packaging materials appropriately.
• Dispose of device and accessories following standard solid biohazard waste procedures.
• Devices can be returned to Abbott Medical for disposal. Contact an Abbott Medical
representative or [e-mail] for instructions.
Warranty
Abbott Medical warrants to buyer that, for a period equal to the validated shelf life of the
product, this product shall meet the product specifications established by the manufacturer
when used in accordance with the manufacturer’s instructions for use and shall be free from
defects in materials and workmanship. Abbott Medical’s obligation under this warranty is limited
to replacing or repairing at its option, at its factory, this product if returned within the warranty
period to Abbott Medical and after confirmed to be defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, ABBOTT MEDICAL DISCLAIMS
ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
See the Terms and Conditions of Sale for further information.
For U.S. --- California Only:
WARNING: This product can expose you to chemicals including ethylene oxide, which is
known to the State of California to cause cancer and birth defects or other reproductive
harm. For more information, go to www.P65Warnings.ca.gov.

ARTEN600038214A
2018-08
Abbott Medical
5050 Nathan Lane North
Plymouth, MN 55442 USA
[phone]
[phone]
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