LeMaitre Pruitt Instrucciones De Uso página 2

Pruitt® Irrigation Occlusion Catheter
(Model Numbers 2102-09, e2102-09)
Instructions for Use - English
Concept
Balloon tipped catheters have been used to occlude vessels for years. Balloon occlusion can
lessen the chance of damage to vessel walls and lining. Often, catheters were not specifically
designed for this application. They did not have a second lumen or access to the vessel distal
to the point of occlusion nor did they have a stopcock to maintain the inflation level of the
balloon. Dr. Pruitt's idea was to design a line of catheters specifically for arterial occlusion
and irrigation.
Description
The Pruitt line of balloon irrigation-occlusion catheters and kits has been specifically
designed and dimensioned for use in the outlined general procedures. The Pruitt line of
catheters features a second lumen designed to allow access to the vessel distal to the point of
occlusion, 2 stopcocks with a luer-lock fitting at the proximal end of the irrigation lumen to
facilitate control of such procedures, a balloon thickness designed to reduce the possibility of
puncture by calcium deposits, and a stopcock to maintain balloon inflation level throughout
the procedure.
Indications
1. To temporarily occlude vessels for the control of bleeding.
2. To access the vessel lumen distal to the point of occlusion.
Applications
1. Occlusion: To temporarily occlude vessels during surgery, position the catheter balloon
with the vessel lumen to the point requiring the occlusion. Inflate the balloon with
sterile saline for injection to occlude the vessel, taking care not to overinflate the balloon
(see recommended inflation capacity chart). Do not inflate the balloon to any greater
volume than necessary to obstruct the blood lumen. Close the inflation stopcock to
maintain balloon inflation. During positioning, the irrigation lumen should be allowed to
aspirate until there is free return of fluid, to reduce the chance of air embolism.
2. Irrigation: Once the catheter is positioned, introduction or withdrawal of materials to
areas distal to the point of occlusion may be accomplished through the irrigation lumen.
This is facilitated through the luer-lock fitting at the base of the irrigation stopcock.
3. Kits: When supplied in kit form, supplemental information inserts will be provided
outlining recommended use.
Contraindications
1. The catheter is not to be used as a dilation catheter.
2. The catheter is not to be used for the introduction of drugs other than saline, heparine,
and contrast media.
3. The catheter is a temporary device and cannot be implanted.
Precautions
1. The catheter is recommended for single use only.
2. Inspect the product and package prior to use and do not use the catheter if there is any
evidence that the package has been punctured or that the catheter has been damaged.
3. Pretest the catheter before use: a) inflate the balloon to the recommended capacity
with air and immerse the balloon in sterile water. If there is any evidence of air escaping
around the balloon or if the balloon will not remain inflated, do not use the product.
b) Also, check the balloon integrity by inflating and deflating with sterile saline for
injection before use. If the balloon does not appear to function normally, do not use the
product.
4. Air or gas should not be used to inflate the balloon if there is a possibility of embolization
with balloon rupture.
5. Make secure connections between all syringes and hubs to avoid the introduction of air.
6. To avoid damage to the fragile latex, do not grasp the balloon with instruments at any
time.
7. Do not inflate the balloon to any greater volume than is necessary to obstruct the blood
flow. DO NOT EXCEED the recommended maximum inflation capacity. See chart for
specific catheter inflation limits.
8. The irrigation lumen of the catheter should be aspirated until there is a free return of
fluid during insertion. This should reduce the chance of air embolism.
9. Caution should be exercised when encountering extremely diseased vessels. Arterial
rupture or balloon failure due to sharp calcified plaque, may occur.
10. Deflate the balloon prior to withdrawing the catheter.
11. The possibility of balloon rupture or failure must be taken into account when considering
the risk involved in a balloon catherization procedure..