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MultiTASC® Dissection/Transection Device
(Model Numbers 4500-03, 4500-04, 4500-05, 4500-06, 4500-07, 4500-08, 4500-09, 4500-10)
Instructions for Use - English
Description
The MultiTASC® Dissection/Transection Device consists of two coaxial metal rings which are connected to a
removable handle through concentric tubes.
The device is designed to dissect an atheromatous core from the vessel wall. The core is then transected and
extracted from the vessel.
Indication for Use
This device is intended for remote endarterectomy of peripheral blood vessels during vascular reconstruction.
Contraindications
The MultiTASC Device is not recommended for the following:
1.
pregnant women,
2.
patients with allergy to any of the device materials,
3.
patients with an aneurysm in the targeted vessel,
4.
patients with severe calcification,
5.
use in coronary, internal carotid arteries, or other vessels of the central circulatory system.
Warnings
1.
Do not use if the package or device is damaged.
2.
Do not use if inner packaging is opened outside a sterile environment.
3.
This device is to be used by a qualified physician.
4.
Do not use if vessel wall layers are overly coherent and the atheromatous segment is difficult to separate from
the vessel.
Precautions
1.
United States Federal and other law restricts this device to sale on or by the order of a physician.
2.
Do not use device past the expiration date printed on the labeling.
3.
This device is single use only. Do not reuse, reprocess, or re-sterilize (reference "Re-sterilization/
Repackaging" section of this document for further details).
4.
Never attempt to use this device without fluoroscopy.
5.
Do not use excessive force to strip/remove atheromatous segments from occluded vessel.
6.
Ensure ALL dissected atheromatous material is removed.
7.
This device is not designed to transect calcified material. Attempted transection of such material may
damage the device. If the rings or shaft of the device become bent, do not attempt to repair the device or use
in the patient. Withdraw from the patient and dispose of the device.
8.
Do not attempt dissection after core transection without inspecting the rings for misalignment. This may be
done under fluoroscopy.
Potential Complications
•
Incisional/puncture site inflammation, hematoma, seroma, or bleeding
•
Superficial or deep wound infection
•
Vessel injury, dissection, perforation or rupture
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