The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the reported leak (loss of fluid column).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.A new sgc was used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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