LeMaitre Pruitt F3 Gebrauchsanleitung Seite 2

INSTRUCTIONS FOR USE
Pruitt® F3™ Carotid Shunt (Outlying)
Model # 2011-10, 2011-11
Pruitt® F3™ Carotid Shunt (Inlying)
Model # 2011-12, 2011-13
Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Rx Only
U.S. Patent Pending
INTRODUCTION
The Pruitt F3 Carotid Shunt is designed to serve as an artifi cial passage connecting two blood vessels, allowing
blood fl ow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in
place by a stabilization technique on both ends of the conduit.
PRODUCT DESCRIPTION
The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal
carotid) and proximal (common carotid) ends of the shunt. The balloons, when infl ated independently, act as a
stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal
carotid arteries. An external safety balloon located on the infl ation arm leading to the distal (internal carotid)
balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it infl ates above
optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-infl ation
and resultant vessel damage.
The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon infl ation. The
infl ation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue
stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety
balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion.
INDICATION
1. Carotid shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood
fl ow between the common and internal carotid arteries.
CONTRAINDICATIONS
1. The Shunt is a temporary device and should not be implanted.
2. The Shunt is not indicated for use in embolectomy, thrombectomy or vessel dilation.
WARNINGS
1. Do not reuse. Do not resterilize. For single use only.
2. Do not use air or gas to infl ate the balloons. Infl ate the balloons with sterile saline.
3. Do not infl ate the internal carotid balloon to any greater volume than is necessary to obstruct blood fl ow
for the internal carotid artery. DO NOT EXCEED the recommended maximum balloon liquid capacity (see
Specifi cations).
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4. Exercise caution when encountering extremely diseased vessels. Arterial rupture or balloon failure due
to sharp calcifi ed plaque may occur. The possibility of balloon rupture must be taken into account when
considering the risks involved in the endarterectomy procedure.
5. Defl ate the balloons prior to Shunt removal. Avoid using excessive force to push or pull the Shunt against
resistance.
PRECAUTIONS
1. Inspect the product and package prior to use and do not use if there is any evidence that the package or the
Shunt has been damaged.
2. The Shunt should be used only by qualifi ed physicians thoroughly familiar with surgical cardiovascular
procedures involving the carotid artery.
3. Pretest the Shunt according to the Pre-Test Procedure prior to patient use to ensure the lumen is free of
obstructions and the balloons are functional.
4. Aspirate the balloons prior to infl ation.
5. Place internal carotid balloon into internal carotid artery and common carotid balloon in common carotid
artery.
6. If the Shunt is not properly maintained in position through balloon stabilization, it may migrate within the
internal carotid artery, potentially scuffi ng the intima.
7. Avoid extended or excessive exposure to fl uorescent light, heat, sunlight, or chemical fumes to reduce
balloon degradation. Excessive handling during insertion, and/or plaque and other deposits within the
blood vessel may damage the balloon and increase the possibility of balloon rupture.
8. Do not grasp the balloon with instruments at any time to avoid damage to the latex.
9. Make secure connections between the syringe and the hub to avoid introduction of air.
10. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted
medical practice and applicable local, state, and federal laws and regulations.
ADVERSE EVENTS
As with all cardiovascular procedures involving the carotid arteries, complications may occur during or following
carotid endarterectomy. These may include, but are not limited to:
• stroke
• transient ischemic attack
• 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
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