Do Not Use Open Or Damaged Packages; Store In A Dry Place - Amplatzer TorqVue Gebrauchsanweisung

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AMPLATZER TorqVue™ Delivery System with Pusher Catheter
Instructions for Use

Do not use open or damaged packages.

Store in a dry place.

Caution: Investigational device limited by U.S. law to investigational use only.
Description
The AMPLATZER TorqVue Delivery System with Pusher Catheter (TorqVue) consists of a delivery
sheath, dilator, loading device, plastic vise, delivery cable and pusher catheter. The TorqVue was
designed specifically to facilitate attachment, loading, delivery and deployment of the AMPLATZER
Membranous VSD Occluder device. The TorqVue consists of the following:
• Delivery Sheath—used to deliver the device
• Touhy-Borst adapter with extension tube and stopcock
• Dilator—used to ease penetration of tissue
• Loading Device—used to introduce the Occluder device into the delivery sheath
• Plastic Vise—facilitates direction control and serves as a "handle" for disconnecting
(unscrewing) the delivery cable from the device
• Delivery Cable—allows placement and recapture of the device
• Pusher Catheter—prevents rotation of the device within the delivery sheath allowing for correct
alignment of the device upon deployment
Intended Use
The AMPLATZER TorqVue Delivery System with Pusher Catheter is intended to facilitate the
attachment, loading, delivery and deployment of the AMPLATZER Membranous VSD Occluder
device.
Indications for Use
The TorqVue Delivery System with Pusher Catheter is indicated for use by interventional
cardiologists to place an AMPLATZER Membranous VSD Occluder device.
Precautions and Warnings
• Ethylene Oxide sterilized for single use only. Do not reuse or resterilize.
• Do not use if package is open or damaged.
• Store in a dry place.
• Use prior to the expiration date on the label.
Potential Complications
Procedures requiring percutaneous catheter introduction should not be attempted by physicians
unfamiliar with the possible complications. Complications may occur at any time during or after the
procedure and may include, but are not limited to:
• Air embolism
• Hematoma at the puncture site
• Infection
• Perforation of the vessel wall
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Procedure
Caution: The procedure should be performed in accordance with the Instructions for Use provided
with the AMPLATZER Occluder Device. General instructions for the Delivery System are provided
below.
1. Follow pre-procedure instructions according to institution protocols and the appropriate
AMPLATZER Occluder device Instructions for Use.
2. Inspect the TorqVue sterile pouch and verify that it is unopened and undamaged. Gently open
the sterile pouch and inspect the Delivery System for damage.
3. Introduce an exchange length 0.035" guidewire according to Occluder device instructions.
4. Flush the dilator and delivery sheath with saline.
5. Insert the dilator into the delivery sheath and secure with the locking mechanism.
6. Advance the delivery sheath and dilator over the guidewire and position according to the
Occluder device instructions.
7. Move the system as one unit until the delivery sheath is properly positioned. Position
guidewire, catheter and delivery sheath according to the Occluder device instructions.
8. Remove the dilator and guidewire.
9. Allow back bleeding to purge all air from the system.
10. Pass the delivery cable through the pusher catheter (CAUTION: This should be performed with
an assistant who should straighten the pusher catheter).
11. Attach a hemostasis valve to the loader and flush saline through the pusher catheter.
12. Advance the delivery cable and pusher catheter through the hemostasis valve and loader.
13. Screw the AMPLATZER Occluder device clockwise onto the tip of the delivery cable until
securely tightened.
14. Align the flat portion of the pusher catheter with the flat portion on the end screw of the device
and push into the capsule.
15. Once securely attached, immerse the device and loader in saline solution and pull the
Occluder device into the loader.
16. Advance the pin vise over the delivery cable to the end of the pusher catheter and tighten to
prevent rotation of the device.
17. Attach the loader to the delivery sheath and without rotation, advance the device to the tip of
the delivery sheath.
18. Position and deploy the device according to occluder device instructions.
19. Confirm positioning of the device. Do not release (unscrew) the device until confirmation of
Occluder device placement is achieved.
20. Once confirmation of Occluder device positioning has been achieved, release the device by
unscrewing with the pin vise in counter clockwise fashion.
21. Follow post-implant procedure instructions according to the appropriate AMPLATZER
Occluder device Instructions for Use.
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