Model Number 7212 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/28/2020 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilation; however, the device snapped upon going in.The procedure was completed with a 2.5 x 15 non-bsc nc balloon catheter.No known patient complications were reported.
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Event Description
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It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilation; however, the device snapped upon going in.The procedure was completed with a 2.5 x 15 non-bsc nc balloon catheter.No known patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 22.9cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
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Search Alerts/Recalls
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