Model Number B1050-100 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat an unspecified lesion.An armada 35 balloon catheter was advanced to the target lesion but it was noted that the distal marker was missing.Therefore, another armada was used to successfully complete the procedure.There was no clinically significant delay and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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The device was returned.Visual and functional inspections were performed on the returned device.The reported missing balloon marker was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation determined the noted missing marker appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
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Search Alerts/Recalls
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