LeMaitre Vascular Over-the-Wire Mode D'emploi page 2

Over-the-Wire LeMaitre® Valvulotome
(Model Numbers 1005-00, 1006-00, e1005-00, e1006-00)
Instructions for Use - English
Description
The Over-the-Wire LeMaitre® Valvulotome is used to cut saphenous vein valves during bypass procedures. The
Centering Hoops keep the head of the Over-the-Wire LeMaitre Valvulotome centered in the vessel and prevents the
valve-cutting blades from damaging the vessel wall. The size of the Centering Hoops and Cutting Blades adjust to
the internal diameter of the vein as the Over-the-Wire LeMaitre Valvulotome is being drawn through the vessel. The
LeMills Valvulotome is provided as an accessory device to cut the last valve set as needed.
Kit includes LeMills Valvulotome.
Indication for Use
The Over-the-Wire LeMaitre Valvulotome is indicated for cutting saphenous vein valves during in-situ bypass.
The LeMills Valvulotome is intended to cut venous valves.
Contraindications
1. pregnant women,
2. patients with allergy to any of the device materials,
3. endarterectomy procedures,
4. thrombolysis procedures,
5. vein stripping procedures,
6. embolectomy procedures, or
7. vessel dilation procedures.
Warnings
1. Do not use if the package or device is damaged.
2. Do not use if packaging is opened outside a sterile environment.
3. The Over-the-Wire Valvulotome and the LeMills Valvulotome are to be used by a qualified physician.
4. Do not insert the Over-the-Wire Valvulotome into a vessel or extract from a vessel in the open position.
5. The Over-the-Wire Valvulotome must be used with an 0.035" Guidewire.
6. Do not open or close the Over-the-Wire Valvulotome while in a coiled configuration.
7. The Over-the-Wire Valvulotome must be flushed with saline or heparinized saline only.
8. Do not pass the Over-the-Wire Valvulotome or LeMills Valvulotome through a vessel that has undergone
synthetic grafting or contains implants.
9. Do not rotate the Over-the-Wire Valvulotome in a vessel.
10. A maximum of 8 passes with the Over-the-Wire Valvulotome may be completed.
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. These devices are single use only. Do not reuse, reprocess, or re-sterilize (reference "Re-sterilization/
Repackaging" section of this document for further details).
4. Keep any dissected portion of the vein straight and avoid twisting the vein during valvulotomy.
5. Use caution when advancing the guidewire past the proximal anastomosis.
6. Use caution when tracking the Over-the-Wire Valvulotome in thrombophlebitic veins.
7. Do not advance the Over-the-Wire Valvulotome with the blades in the open position.
Potential Complications
• Vessel damage
• Vessel occlusion/ stenosis
• Hematoma
• Hemorrhage
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