LeMaitre Pruitt F3 Mode D'emploi page 3

• neurologic complications
• embolization of blood clots, areteriosclerotic plaque, or air
• hypertension or hypotension
• infection
• intimal disruption
• arterial dissection
• vessel perforation and rupture
• hemorrhage
• arterial thrombosis
• aneurysms
• arterial spasm
How Supplied
The Shunt is supplied sterile and nonpyrogenic. The sterility of the package is assured as long as it is unopened and undamaged.
Procedure
IMPORTANT: A variety of surgical techniques may be used when using the Shunts; therefore, the surgeon is best advised to use the method
which his/her own practice and training dictate to be best for the patient. Specific surgical techniques are left to the discretion of the
surgeon.
Balloon Pretest Procedure (Perform Before Patient Use)
1. Inflate both balloons up to the maximum recommended volumes with sterile saline and inspect for leaks. If there is
any evidence of leaks around the balloons or if either balloon will not remain inflated, do not use the product.
NOTE: The common carotid balloon is designed to inflate partially to minimize pressure on the common carotid artery while
maintaining position.
2. Ensure that the movable sleeve hangs loosely on the infusion area of the distal (internal carotid) lumen and DOES
NOT cover the external safety balloon as it will render the safety balloon inoperable and subject the internal carotid
artery to possible injury by over-inflation of the internal carotid balloon.
3. Before patient use, aspirate the balloons completely prior to inflation of the balloons.
T-Port Pretest (Perform Before Patient Use)
1. Place a gloved finger over the opening near the common carotid (large blue balloon) end and inject sterile saline
through the T-Port stopcock. Fluid should flow through the opening near the internal carotid (small balloon) end.
2. Place a gloved finger over the internal carotid (small balloon) end and inject sterile saline through the T-Port
stopcock. Fluid should flow through the opening near the common carotid (large blue balloon) end.
3. Do not use the Shunt if fluid does not flow through both openings.
Procedure for T-Port Models 2011-10, 2011-12, 2012-10, 2012-12, 2013-10, e2011-10, e2011-12, e2012-10, e2012-12,
e2013-10
1. Expose the carotid artery and perform the arteriotomy in the usual manner.
2. Place a clamp on the proximal (common carotid) end of the Shunt before the T-Port.
3. Place the distal (internal carotid) end of the Shunt into the internal carotid artery.
4. Attach to 3 ml syringe to the white stopcock and SLOWLY inflate the internal carotid artery balloon with up to 0.25
ml of sterile saline (Figure A).
5. As inflation progresses, carefully observe back-bleeding from the internal carotid artery around the Shunt. The
back-bleeding will diminish as the balloon expands. When the balloon is inflated sufficiently to occlude the artery,
back-bleeding around the shunt will stop, there will be a feeling of slight resistance to further inflation and/or there
will be a slight distention of the external safety balloon. This is the end-point: STOP INFLATION IMMEDIATELY AT THIS
POINT. The external safety balloon should not be inflated (Figure B).
6. Close the white stopcock and slide the movable sleeve over the external safety balloon. This will prevent reflux from
the internal carotid balloon into the external safety balloon and prevent subsequent loss of vessel occlusion (Figure
E).
NOTE: The internal carotid balloon may accidentally become dislodged from its position by over-inflation, handling of the artery,
or pulling on the Shunt. This may result in spontaneous decompression of the internal carotid balloon with reflux into the external
safety balloon and loss of occlusion in the artery. Placement of the sleeve or sheath over the external safety balloon prevents this
potential problem.
IMPORTANT: Should the internal carotid balloon be over-inflated, causing the external safety balloon to inflate (Figure C), BOTH
balloons must be deflated. After both balloons have been deflated (Figure D), SLOWLY inflate the internal carotid artery balloon
with up to 0.25 ml of sterile saline without inflating the external safety balloon (Figure B).
7. Open the T-Port stopcock and allow blood to back-bleed through the T-Port of the shunt observing for air bubbles
and/or atheromatous debris.
8. When no debris or bubbles are noted, close the T-Port stopcock and move the clamp from the proximal (blue
common carotid) end to the distal (internal carotid) end of the Shunt beyond the T-Port.
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