Exemption number e2019001.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported for leaks from this lot.All available information was investigated and a definitive cause for the reported steerable guide catheter (sgc) leak (loss of fluid column during sgc preparation) could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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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 sgc failed to hold column.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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