The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other complaints reported from this lot.The investigation determined that the reported difficulties were related to circumstances of the procedure.The failure to advance was likely due to anatomical conditions, which were reported as heavily calcified with 80% stenosis.Additionally, it is likely that the tip of the absolute pro was angled in the anatomy such that the during the attempt to withdrawal, the tip caught on the distal end of the 6fr sheath causing difficultly removing.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
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