| Catalog Number KCFW-8.0-38-55-RB- |
| Device Problems
Separates;
Device, removal of (non-implant)
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| Event Date 05/27/2004 |
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Event Type
Injury
Patient Outcome
Required Intervention;
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Event Description
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A diagnostic aortagram was performed viewing the iliac arteries.
After the angiogram, it was decided to stent and perform an angioplasty of the right iliac artery from the existing left femoral approach using the up and over technique.
The introducer sheath was advanced into the iliac system.
A stent was deployed and placed across the lesion, however, the delivery system of the stent had kinked during placement.
The stent was then post dilated with a balloon catheter.
After dilatation, the balloon would not deflate and pull back into the introducer sheath with the normal exertion.
Additional force was applied during the attempted withdrawal of the balloon back into the sheath.
The balloon then ruptured and the distal tip separated.
The right femoral artery was then accessed in an attempt to retrieve the detached section of the balloon.
A 11 french sheath was placed in the right groin and the wire guide was snared and pulled retrograde through the 11 french sheath, providing access through the left and right groins with the same wire guide that was still coaxially on the balloon fragment.
Ultimately, the balloon fragment was retrieved.
Upon removing the introducer sheath from the right groin, the outer material of the sheath separated into two pieces.
The proximal portion of the sheath was removed, with the distal portion remaining in the pt coaxially on the wire guide.
A snare was introduced through the 11 french sheath in the right groin and the remaining sections of the sheath were retrieved from the pt.
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Manufacturer Narrative
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Event evaluation: an examination of the sheath tubing noted the separation occurred approximately 34 centimeters from the hub, with the inner coils exposed.
The distal section of the tubing had also accordioned with multiple kinks.
Longitudinal scrape marks were found on the distal section of the tubing.
Utilizing a.
038 wire guide, co was able to dislodge the gold marker band and a 2 centimeter section of the sheath's inner liner.
Under microscopic examination, the inner liner segment was found shredded.
Concerning the info provided, and the characteristics displayed, it is feasible to say that the sheath was damaged during an attempt to remove the balloon.
Once damaged, excessive resistance was encountered during removal, leading to the device separation.
This incident most likely occurred as a result of procedurally related circumstances.
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Search Alerts/Recalls
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