LeMaitre Pruitt Instrucciones De Uso página 2

Pruitt® Occlusion Catheter
(Model Numbers 2103-36, 2013-46, 2013-56, e2103-36, e2013-46, and e2013-56)
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.
Potential Complications
• Infection
• Local Hematomas
• Intimal disruption
• Arterial dissection
• Vessel perforation and rupture
• Hemorrhage
• Arterial thrombosis
• Embolism
• Hypertension or hypotension
• Aneurysms
• Arterial spasms