The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no lot specific product issue.All available information was investigated and a definitive cause for the reported leak 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 (sgc) leak.It was reported that during preparation of the steerable guide catheter (sgc), the sgc failed to hold column twice, the sgc leaked and bubbles were observed.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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