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 other complaints reported from this lot.All available information was investigated and a definitive cause for the reported leak in this incident could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action is required.
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This filed to report a leak.It was reported that during preparation of a steerable guide catheter (sgc), the sgc failed to hold column indicating a leak.Trouble shooting was performed, but the sgc would not hold column.The sgc was not used in the patient and the procedure was successfully completed with a new sgc.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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