LeMaitre Pruitt F3 Mode D'emploi page 5

Procedure for Models 2012-11 and 2012-13
1. Expose the carotid artery and perform the arteriotomy in the usual manner.
2. Place the distal (internal carotid) end of the Shunt into the internal carotid artery.
3. Attach a 3 ml syringe to the white stopcock and SLOWLY infl ate the internal carotid balloon with up to 0.25 ml of sterile saline.
(Figure A)
4. 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)
5. 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).
6. Place the proximal (blue common carotid) end of the Shunt into the common carotid artery.
7. 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.
8. Clamp across the Shunt lumen and remove the clamp on the common carotid artery. Slowly remove the clamp that is across the
Shunt and observe for air bubbles and/or atheromatous debris. If no bubbles or debris are seen, fully remove the clamp. Proceed
with the procedure.
9. When the endarterectomy is completed, defl ate the balloons, remove the Shunt and close the arteriotomy in the usual manner.
Specifi cations
Model Description Usable Length
2011-10 Pruitt F3 Carotid Shunt 31 cm
with T-port (Outlying)
2011-12 Pruitt F3 Carotid Shunt 15 cm
with T-port (Inlying)
Pruitt F3 Carotid Shunt
2012-10 31 cm
with T-Port (Outlying)
Pruitt F3 Carotid Shunt
2012-11 31 cm
(Outlying)
Pruitt F3 Carotid Shunt
2012-12 15 cm
with T-Port (Inlying)
Pruitt F3 Carotid Shunt
2012-13 15 cm
(Inlying)
Pruitt F3 Carotid Shunt
2013-10 31 cm
with T-Port (Outlying)
Stopcock Color
Common Carotid Balloon Blue
Internal Carotid Balloon White
T-Port Red
Storage Shelf Life
The shelf life is indicated by the USE BY date on the package label. The USE BY date printed on each label is NOT a sterility date. The USE
5
Common Infl ation Safety Balloon Sheath
Diameter
Lumen Markings Color
10 French Blue Lumen Yellow
(3.3 mm)
10 French Blue Lumen Yellow
(3.3 mm)
9 French
Blue Lumen Yellow
(3.0 mm)
9 French
Blue Lumen Yellow
(3.0 mm)
9 French
Blue Lumen Yellow
(3.0 mm)
9 French
Blue Lumen Yellow
(3.0 mm)
8 French
Blue Lumen Yellow
(2.67 mm)
Balloon Maximum Balloon Diameter at
Liquid Capacity Maximum Liquid Capacity
1.5 ml 14 mm
.25 ml 8 mm
N/A N/A