Catalog Number SGC0702 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.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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This is being filed to report the broken flush port.It was reported that during preparation of the steerable guide catheter (sgc), the flush port of the hemostasis valve on the sgc broke.The sgc was not used and was replaced with another sgc.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
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Manufacturer Narrative
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All available information was investigated, and the reported break was confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported break of the hemostasis valve as a potential product 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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