(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 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 leak.It was reported that during preparation of the steerable guide catheter (sgc), loss of column was noted.The device was de-aired and tested five additional times; however, loss of column was still noted.The stopcock was exchanged, but a leak was noted in the hemostatic valve.There were no visible defects.The sgc was not used in the anatomy and was replaced.A new sgc was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
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