Amplatzer TorqVue LP Delivery System Instrucciones De Uso página 13

Potential Adverse Events
Potential adverse events associated with the device include, but are not limited to, air
embolism, arteriovenous fistulae, arrhythmia, bleeding at the access site, brachial plexus
injury, cardiac tamponade, death, dissection, endocarditis, hematoma, hemodynamic
compromise, infection, myocardial infarction, perforation, peripheral pulse loss, stroke,
thrombosis, transient ischemic attack (TIA), valve damage, vascular access site injury,
vascular occlusion, vessel damage
Procedure
CAUTION: The procedure should be performed in accordance with the Instructions
for Use provided with the appropriate AMPLATZER™ device. General instructions
for the TorqVue™ LP Delivery System are provided below.
1. Follow pre-procedure instructions according to institution protocols and the
Instructions for Use provided with the AMPLATZER™ device.
2. Inspect the TorqVue™ LP Delivery System sterile pouch and verify that it is
unopened and undamaged. Gently open the sterile pouch and inspect the delivery
system for damage.
3. Wipe the outside and flush the inside of the catheter with sterile saline solution.
4. Gain venous or arterial access in routine fashion. Ensure appropriate size introducer
sheath is used to gain access.
5. Introduce guidewire according to the Instructions for Use provided with the
AMPLATZER™ device.
6. Flush the delivery catheter with sterile saline solution.
7. Attach a hemostasis valve to the delivery catheter.
8. Advance the delivery catheter over the guidewire and position according to the
Instructions for Use provided with the AMPLATZER™ device. Use care when
passing the delivery catheter through vessels and tissue to avoid damaging vessels
and cardiac tissue.
9. Remove the guidewire.
10. Allow back-bleeding to purge all air from the system by holding the valve below the
plane of the patient's body and opening the stopcock. A syringe may also be
attached to the valve and air aspirated by back-flushing the system. Close stopcock
when complete.
11. Advance the delivery wire through the loader.
12. Thread the selected AMPLATZER™ device clockwise onto the tip of the delivery
wire until securely tightened. To ensure proper release of implantable device, rotate
the device counter-clockwise 1/8 of a turn.
13. Immerse the device and loader in sterile saline solution and pull the device into the
loader.
14. Introduce the loader through the hemostasis valve and into the delivery catheter
until the loader no longer advances. Hold the loader in place while transferring the
device into the delivery catheter. Use care when advancing a device through the
delivery catheter to avoid damaging vessels and cardiac tissue.
CAUTION: If unable to transfer device into the delivery catheter, retrieve device,
reposition loader and transfer device into the delivery catheter.
15. Push device to the distal tip of the delivery catheter. Do not rotate delivery wire.
Remove the loader.
16. Position the device according to the Instructions for Use for the AMPLATZER™
device and confirm placement.
CAUTION: Do not release the device (unscrew the delivery wire) until device
placement is confirmed.
2