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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 06/08/2022 |
Event Type
malfunction
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Event Description
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This is filed to report the steerable guide catheter leak.It was reported that during preparation of the steerable guide catheter (sgc), the hemostatic valve failed to hold column, 4-5 times.The device was not used, there was no patient involvement.A new sgc was used to complete the procedure.There was 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 was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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The reported steerable guide catheter (sgc) leak was not 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 did not indicate a lot-specific quality issue.All available information was investigated, and a cause for the reported leak 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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