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. Specifi c surgical techniques are left to the discretion of the
surgeon.
Balloon Pretest Procedure (Perform Before Patient Use)
1. Infl ate 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 infl ated, do not use the product.
NOTE: The common carotid balloon is designed to infl ate 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-infl ation of the internal carotid balloon.
3. In order to properly defl ate the balloon(s), remove the syringe and open the stopcock. The balloon(s) should then
defl ate unaided.
4. Before patient use, aspirate the balloons completely prior to infl ation of the balloons.
T-Port Pretest (Perform Before Patient Use)
1. Place a gloved fi nger over the opening near the common carotid (large blue balloon) end and inject sterile saline
through the T-Port stopcock. Fluid should fl ow through the opening near the internal carotid (small balloon) end.
2. Place a gloved fi nger over the internal carotid (small balloon) end and inject sterile saline through the T-Port
stopcock. Fluid should fl ow through the opening near the common carotid (large blue balloon) end.
3. Do not use the Shunt if fl uid does not fl ow through both openings.
Procedure for T-Port Models 2011-10, 2011-12, 2012-10, 2012-12, 2013-10
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 a 3 ml syringe to the white stopcock and SLOWLY infl ate the internal carotid artery balloon with up to 0.25 ml
of sterile saline (Figure A).
5. As infl ation 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 infl ated suffi ciently to occlude the artery,
back-bleeding around the shunt will stop, there will be a feeling of slight resistance to further infl ation 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 infl ated (Figure B).
6. Close the white stopcock and slide the movable sleeve over the external safety balloon. This will prevent refl ux 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-infl ation, handling of the artery,
or pulling on the Shunt. This may result in spontaneous decompression of the internal carotid balloon with refl ux 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-infl ated, causing the external safety balloon to infl ate (Figure C), BOTH
balloons must be defl ated. After both balloons have been defl ated (Figure D), SLOWLY infl ate the internal carotid artery balloon
with up to 0.25 ml of sterile saline without infl ating 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
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