This is filed to report the steerable guide catheter leak.It was reported that during preparation of the steerable guide catheter (sgc) the sgc, failed to hold column as soon as the dilator was placed.The sgc 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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The device was returned for analysis.All available information was investigated, and the reported issue 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 similar complaints reported from this lot.The investigation was unable to determine a cause for the reported leak (loss of fluid column).There is no indication of a product issue with respect to manufacture, design, or labeling.
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