The device was not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and a cause for the reported leak (loss of fluid column) during device preparation could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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This is filed to report during preparation, the sgc failed to hold water column.It was reported that during functional testing of the steerable guiding catheter (sgc), it was observed that the hemostatic valve didn't hold the water column.Therefore, this sgc was not used and a new sgc was used in the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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