Directions For Use - AGA Medical AMPLATZER Mode D'emploi

9. Directions for Use

1. Perform a right heart catheterization.
2. Determine the diameter and length of the patent ductus arteriosus using angiography. See Figure 2 for
sizing locations.
DUCT LENGTH
Figure 2. AMPLATZER Duct Occluder II sizing locations.
3. Select the appropriate occluder according to Table 1.
4. Attach the hemostasis valve to the delivery catheter. Flush the delivery catheter.
5. Introduce the guidewire using either an arterial or a venous approach, and cross the patent ductus arteriosus.
Advance the delivery catheter over the guidewire, and cross the patent ductus arteriosus.
6. Confirm the position of the delivery catheter by a test injection of contrast medium.
7. Pass the delivery wire through the loader, then attach the occluder to the tip of the delivery wire by rotating it
clockwise until it is secure. To ensure proper release, rotate the occluder counter-clockwise 1/8 of one turn.
8. Immerse the occluder and the loader in saline solution and pull the occluder into the loader.
9. Slowly remove the guidewire from the delivery catheter. Allow back-bleeding through the side arm valve to purge
all air from the system.
10. 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 occluder into the delivery catheter.
11. Push the occluder to the distal tip of the delivery catheter. Do not rotate the delivery wire. Remove the loader.
12. Deploy the distal disc and slowly retract the system until the distal disc conforms to the vessel wall. Confirm
placement of the distal disc with fluoroscopy.
13. While maintaining tension on the delivery wire, deploy the waist and the proximal disc by carefully retracting the
delivery catheter.
14. Perform test injection to verify position of the occluder.
15. If the position of the occluder and conformance of the discs to the vessel walls is unsatisfactory:
a. Stabilize the delivery wire and re-advance the delivery catheter until the occluder is completely within
the catheter.
b. Reposition the occluder and deploy it again, or remove the occluder from the patient.
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DUCT DIAMETER