Potential Adverse Events; Directions For Use - Amplatzer Vascular Plug II Instrucciones De Uso

Potential Adverse Events

Potential complications include, but are not limited to: vessel perforation or migration of
the device.

Directions for Use

1. Access the vessel and perform an angiogram using standard technique to measure the
diameter of the vessel at the desired occlusion site.
2. Select an AMPLATZER Vascular Plug II with a diameter approximately 30-50% larger than
the vessel diameter at the occlusion site. Ensure that the occlusion site has sufficient
length to accommodate the deployed device length so that the device will not obstruct other
vessels or anatomical structures.
3. Flush the hoop dispenser and loader with sterile saline until fluid exits the distal tip to
purge air from the loader.
4. Remove the device (in the loader) and the delivery wire from the hoop dispenser.
5. Select a delivery catheter (see Table 1 for delivery catheter size).
NOTE: If the inner diameter of the original access catheter is sufficient for the device size
selected, that catheter may be used for delivery.
NOTE: The delivery catheter length should be no more than 100 cm.
6. Advance the delivery catheter over the guide wire until the distal tip of the catheter is at the
distal edge of the occlusion site.
7. Remove the guide wire.
8. Insert the loader into the delivery catheter through the Y-connector or hemostasis valve.
NOTE: A single Y-Connector kit is recommended for use with the AMPLATZER Vascular
Plug II. B. Braun Medical Inc., Order No. 610400
9. Allow blood backflow, or aspirate the system to ensure air is purged from the catheter
and loader.
CAUTION: Do not overtighten Y-connector screw to avoid damaging loader.
10. Push on the delivery wire to advance the device into the delivery catheter. Remove the
loader from the wire if desired.
11. Advance the delivery wire and device to the distal end of delivery catheter. Do not twist or
rotate the delivery wire during advancement to ensure device does not prematurely detach.
12. Hold the delivery wire in place and slowly withdraw the delivery catheter to deploy the
device at the occlusion site.
13. Verify position of the device.
14. If device position is unsatisfactory:
a. Stabilize the wire and re-advance the delivery catheter until the device is completely within the
catheter.
b. Reposition and deploy, or remove the device from the patient.
15. If the device position is satisfactory:
a. Attach the plastic vise to the wire, and release the device by rotating the delivery
wire counterclockwise until it separates from the device.
b. Remove the delivery catheter and wire from the patient.
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