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 and no clinically significant delay during the procedure.No additional information regarding this issue was provided.
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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 similar incidents reported from this lot.All available information was reviewed and without the device to analyze, a cause for the reported leak/splash (loss of fluid column during prep) could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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