LeMaitre Pruitt F3-S Mode D'emploi page 3

• infection
• intimal disruption
• arterial dissection
• vessel perforation and rupture
• hemorrhage
• arterial thrombosis
• aneurysms
• arterial spasm
How Supplied
The Shunt is supplied sterile. 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. 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 large blue balloon end and inject sterile saline through the red
T-Port stopcock. Fluid should fl ow through the opening near the small clear balloon end.
2. Place a gloved fi nger over the small clear balloon end and inject sterile saline through the red T-Port stopcock. Fluid
should fl ow through the opening near the 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 2016-10, 2016-11, 2014-10, 2014-12, 2015-10
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 between the blue balloon and the T-Port arm.
3. Place the distal end (clear balloon) of the Shunt into the internal carotid artery.
4. Attach a 3 ml syringe to the white stopcock and SLOWLY infl ate the clear 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. This is the
end-point: STOP INFLATION IMMEDIATELY AT THIS POINT. (Figure B)
6. Close the white stopcock.
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. Move the clamp to the distal (internal carotid) end
of the Shunt between the white balloon and the T-port arm.
9. Place the proximal (blue balloon) end of the Shunt into the common carotid artery.
10. Attach a 3 ml syringe to the blue stopcock and slowly infl ate the blue common carotid artery balloon with up to
1.5 ml of sterile saline. Close the blue stopcock.
11. Open the T-Port stopcock and allow blood to fl ow through the T-Port of the Shunt observing for air bubbles and/or
atheromatous debris.
12. When no debris or bubbles are noted, close the T-Port stopcock and remove the clamp on the distal (internal carotid)
end of the Shunt. Proceed with the procedure.
13. When the endarterectomy is completed, defl ate the balloons, remove the Shunt and close the arteriotomy in the
usual manner. (Figure C)
Procedure for Models 2014-11 and 2014-13
1. Expose the carotid artery and perform the arteriotomy in the usual manner.
2. Place the distal (clear balloon) end of the Shunt into the internal carotid artery.
3. Attach the 3 ml syringe to the white stopcock and SLOWLY infl ate the clear balloon with up to 0.25 ml of sterile saline.
(Figure A)
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