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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 05/02/2022 |
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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This is filed to report the steerable guide catheter leak.It was reported that during preparation of the steerable guide catheter (sgc), fluid column was lost.This occurred three separate times; therefore, the device was not used and was replaced.The dilator that was successfully used with the second sgc was tested with the sgc that failed to hold column to see if the sgc would hold column this time.When using this dilator, the sgc successfully held column, therefore, it is suspected the issue was with the dilator.There was no clinically significant delay in the procedure.No additional information was provided.
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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 identified no other complaints reported from this lot.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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