Model Number M001BP90720B0 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Intimal Dissection (1333)
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Event Date 10/27/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the balloon blade was partially detached and a vessel dissection occurred.A 7.00mm/2cm peripheral cutting balloon¿ was selected to dilate a stenosed arteriovenous fistula.Immediately after the stenosis was dilated it was noted that one of the balloon blades was partially detached.A digital subtraction angiography (dsa) run demonstrated active contrast extravasation that was successfully treated with a covered stent.No further patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.Although the blades did not detach from the balloon, it was noted that a section of the blade and pad was lifted on the balloon.One of the blades/pads was lifted on the balloon.Approximately 7mm of the proximal section of the blade and pad was lifted on the balloon.The remaining three blades were inspected and no issues were noted.No tears or holes were identified in the balloon.The balloon was not refolded.Attempts to inflate the balloon failed.The device was immersed in warm water (37 degrees celsius), however the balloon failed to inflate.The restriction experienced is consistent with the build-up of solidified contrast media in the balloon/inflation lumen.No issues were identified with the tip.A visual and tactile examination identified no damage along the entire length of the shaft.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was reported that the balloon blade was partially detached and a vessel dissection occurred.A 7.00mm/2cm peripheral cutting balloon¿ was selected to dilate a stenosed arteriovenous fistula.Immediately after the stenosis was dilated it was noted that one of the balloon blades was partially detached.A digital subtraction angiography (dsa) run demonstrated active contrast extravasation that was successfully treated with a covered stent.No further patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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