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Pruitt F3®-S Polyurethane Carotid Shunt (Outlying) (Model # 2016-10, 2014-10, 2014-11, 2015-10)
Pruitt F3®-S Polyurethane Carotid Shunt (Inlying) (Model # 2016-11, 2014-12, 2014-13)
Instructions for Use - English
Introduction
The Pruitt F3®-S Polyurethane 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®-S Polyurethane 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.
The Pruitt F3®-S Polyurethane 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. 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.
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. Described procedures are provided for informational purposes only. Each physician must determine the
appropriate use of this device for each patient.
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 clear balloon into internal carotid artery and blue 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 damaging 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 balloon.
9.
Make secure connections between the syringe and the hub to avoid introduction of air.
10.
Dispose of used product in accordance with established hospital protocols for biohazards.
11.
Do not reinsert the Shunt once it has been removed, it may become occluded from stagnant blood left in the Shunt.
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
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