Model Number SGC0701 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2021 |
Event Type
malfunction
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Event Description
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This is being filed to report the leak.It was reported that during preparation of the steerable guide catheter (sgc), fluid column was lost multiple times therefore the sgc was not used.There was no patient involvement and no clinically significant delay to the intended procedure.No additional information was provided.
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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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Manufacturer Narrative
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All available information was investigated and the reported sgc leak/splash (loss of fluid column) was not confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and a cause for the reported leak in this complaint could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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