LeMaitre Pruitt Mode D'emploi page 2

Pruitt® Occlusion Catheter
(Model Numbers 2103-36, 2103-46, 2103-56, e2103-36, e2103-46, and e2103-56)
English — Instructions for Use
Concept
To temporarily occlude a blood vessel without using a clamp or ties. The balloon conforms to the
diseased interior wall of the vessel providing occlusion with less chance of damage to the vessel
wall and lining.
Description
Balloon-tipped catheters have been used to occlude vessels for years. The catheters used have not
been specifically designed for this application. The catheters used were too long, have too large a
catheter body, and have openings for blood flow that must be clamped off.
Dr. Pruitt's ideas was to design a catheter to temporarily occlude vessels which had dimensions that
would make it more useful and less trouble to work around.
Storage
The Occlusion Catheters should be stored in a cool dark area away from fluorescent lights and
sunlight to prevent premature deterioration of the latex balloon. The recommended maximum shelf
life (use by date) is shown on the label.
Catheter Inspection And Testing
The Pruitt Occlusion Catheter is supplied in sterile peel-open packages. Inspect the package and
do not use the catheter if there is any evidence that the package has been punctured or that the
catheter has been damaged.
Inflate the balloon to the recommended capacity with air and immerse the balloon in sterile water.
If there is any evidence of air bubbles escaping around the balloon or if the balloon will not remain
inflated, do not use the catheter. Federal law (U.S.A.) restricts this product to sale by or on the order
of a physician.
Indications
The occlusion of vessels both arterial and venous for the control of bleeding.
Contraindications
Not for use as a dilation catheter.
Precautions
1. This catheter is a temporary device and can not be implanted.
2. The occlusion catheter is recommended for a single use only.
3. Check the balloon integrity by using sterile saline for injection before use.
4. DO NOT EXCEED RECOMMENDED INFLATION CAPACITITES.
5. Air or gas should not be used to inflate the balloon if there is a possibility of embolization with
balloon rupture.
6. Make secure connection between the syringe and hub to avoid the introduction of air.
7. To avoid damage, do not grasp the balloon with instruments during insertion.
8. Do not inflate the balloon to any greater volume than necessary to obstruct blood flow.
9. Deflate the balloon prior to withdrawing the catheter.
10. The possibility of balloon rupture must be taken into account when considering the risk involved
in a balloon catherization procedure.
11. Caution: This Product Contains Natural Rubber Late Which May Cause Allergic Reactions.
12. Aspirate before inflation
Potential Complications
• Infection
• Local Hematomas
• Intimal disruption
• Arterial dissection
• Vessel perforation and rupture
• Hemorrhage
• Arterial thrombosis
• Embolism
• Hypertension or hypotension
• Aneurysms
• Arterial spasms
• Arteriovenous fistula formation
• Balloon rupture
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