Amplatzer TorqVue Instrucciones De Uso página 5

Potential Complications
Procedures requiring percutaneous catheter/guidewire 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
CAUTION: The procedure should be performed in accordance with the Instructions for Use
provided with the AMPLATZER Occluder device. General instructions for the TorqVue Exchange
System are provided below.
Procedure
1. Peel open the package and flush the delivery sheath, dilator and loader using sterile
heparinized normal saline or a similar isotonic solution by connecting a syringe to the luer hub
of each component.
2. Insert the dilator into the delivery sheath and secure with the locking mechanism.
3. Screw the delivery cable to the capsule located on the proximal end of the original delivery
cable thus doubling its length.
4. Once securely attached, remove the original delivery sheath from the patient and discard.
5. Introduce the dilator/delivery sheath exchange assembly over the lengthened cable assembly
through the groin. Once the delivery sheath has reached the inferior vena cava, remove the
dilator to allow back bleeding to purge all air from the system.
6. Advance the delivery sheath over the cable through the communication and disconnect the
secondary cable.
7. Proceed with device recapture and/or deployment according to the instructions provided with
the AMPLATZER Occlusion device.
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