All available information was investigated and the reported steerable guide catheter (sgc) leak was not confirmed during return device analysis as no issues were noted during testing.A review of the lot history record revealed no manufacturing nonconformities reported to this lot that would have resulted in this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated and a conclusive cause for the reported leak could not be determined in this complaint.There is no indication of a product issue with respect to manufacture, design or labeling.
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This is filed to report a leak.It was reported that during preparation of the steerable guide catheter (sgc), a loss of fluid column occurred.No aspiration was performed and the physician decided to not use the sgc; therefore, it was replaced.There was no clinically significant delay in the procedure.No additional information was provided.
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