Catalog Number SGC0702 |
Device Problems
Break (1069); Leak/Splash (1354); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2021 |
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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This is filed to report leak from the three-way stopcock of the dilator.It was reported that while preparation of the mitraclip devices, the nurse took the steerable guide catheter (sgc) and the dilator out of the package and checked them for damage, the three-way stopcock of the dilator was closed and flushed but there was a leak under the flush port of the dilator.The flush port was broken.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Subsequent to the initial filed report additional information reported that the dilator rotating hemostatic valve was broken.
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Manufacturer Narrative
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The returned device analysis confirmed the reported dilator rhv separation.The reported leak could not be replicated in a testing environment due to the returned condition of the device (rhv was returned separated from the dilator).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history identified no similar complaints from the lot.Based on the information provided and the results of the device analysis the reported dilator rhv separation resulting in a leak appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.H4 medical device problem code 1069 was removed and replaced with code 1562.
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Search Alerts/Recalls
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