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Pruitt F3® Carotid Shunt (Outlying) (Model # 2011-10, 2012-10, 2012-11, 2013-10, e2011-10, e2012-10, e2012-11,
e2013-10)
Pruitt F3® Carotid Shunt (Inlying) (Model # 2011-12, 2012-12, 2012-13, e2011-12, e2012-12, e2012-13)
Instructions For Use - English
LATEX
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).
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 cardiovascular surgical procedures involving
the carotid artery.
3.
Pretest the Shunt according to the pretest 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
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