3
Directions for Use
Materials recommended for use with the delivery system
Exchange-length 0.035-inch guidewire
Procedure
CAUTION: Refer to the instructions for use provided with the device when placing an AMPLATZER device using an
AMPLATZER TorqVue Delivery System.
General instructions for the AMPLATZER TorqVue Delivery Systems are provided below.
1. Select the appropriate delivery system for use with the device being delivered. Refer to Table 1 and Table 2 to select a
delivery system by AMPLATZER device size, or refer to Table 3 to select the delivery system with a sheath that has the
correct inner diameter as indicated in the device’s instructions for use.
2. Prepare the delivery system for use:
- Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use the components if the sterile
barrier has been compromised.
- Gently open the sterile pouch and inspect the components for damage. Do not use damaged or kinked components.
- Flush all components with sterile saline.
- Wipe the dilator and sheath with sterile gauze moistened with sterile saline to remove any foreign material.
3. Access the desired vessel.
4. Place the guidewire according to the device’s instructions for use.
5. Insert the dilator into the sheath. You may encounter resistance as the dilator reaches the distal end of the sheath
because the end of the sheath is tapered.
6. Turn the rotating luer on the dilator clockwise to lock the components together.
7. Advance the dilator and sheath over the guidewire until the sheath is positioned according to the device’s instructions for
use.
8. Turn the rotating luer on the dilator counterclockwise to unlock the dilator. Slowly remove the dilator from the sheath.
WARNING: Remove the dilator slowly to prevent an ingress of air.
9. Allow blood backflow to purge any air from the sheath.
10. Attach the hemostasis valve to the proximal end of the loader and flush with sterile saline.
CAUTION: Use the hemostasis valve to impede blood backflow during the implant procedure.
11. Capture the device in the loader according to the device's instructions for use.
12. Attach the distal end of the loader to the proximal end of the sheath. Turn the rotating luer on the loader clockwise to lock
the components together. Remember to close the stopcock on the hemostasis valve.
AMPLATZER Muscular VSD Occluder
4 mm
6–10 mm
12 mm
14 mm
16 mm
18 mm
Table 3. Delivery System Dimensions
Delivery system
(sheath) size
Inner diameter of
sheath
Outer diameter of
sheath
5 Fr
1.83 mm (0.07 in)
2.51 mm (0.10 in)
6 Fr
2.11 mm (0.08 in)
2.79 mm (0.11 in)
7 Fr
2.44 mm (0.10 in)
3.18 mm (0.13 in)
8 Fr
2.69 mm (0.11 in)
3.45 mm (0.14 in)
9 Fr
3.00 mm (0.12 in)
3.81 mm (0.15 in)
10 Fr
3.30 mm (0.13 in)
4.14 mm (0.16 in)
12 Fr
3.99 mm (0.16 in)
4.80 mm (0.19 in)
Table 2. Compatibility Chart for TorqVue 180° Delivery System and AMPLATZER Devices
180° Delivery System Sizes
5 Fr
6 Fr
7 Fr
8 Fr
9 Fr