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Model Number 24716 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation by mfr: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 1.1cm from the tip.The device was tracked over a test guidewire and there were no issues.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on device analysis completed on 01-mar-2022.It was reported that balloon damage occurred.The target lesion was located in the right leg angiogram.A 6.0x220x150 sterling balloon catheter was advanced for dilation.The physician was attempting to plasty a diseased portion of superficial femoral artery prior to ivus imaging to be certain the catheter would track.Unfortunately, the balloon at some point in the lesion was defective.The physician utilized another shorter balloon catheter and a ranger dcb to complete the case without issue.No patient complications were reported.However, returned device analysis revealed balloon pinhole.
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Search Alerts/Recalls
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