It was reported that this was a procedure to treat a highly stenosed right popliteal artery.The armada 35 balloon catheter was inserted and attempted to be advanced.However, during advancement, the shaft became stretched.The physician decided to remove the device and replace it.It was noted that there were no issues during removal.No adverse patient effects occurred and there was no clinically significant delay in the procedure.No additional information was provided.
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Visual analysis was performed on the returned device.The reported difficulty advancing was unable to be confirmed due to the condition of the returned device.The reported stretching was confirmed.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 identified no other complaints reported from this lot.The investigation determined that the reported difficulties were due to circumstances of the procedure.It is likely that anatomical conditions contributed to the reported difficulty advancing as the lesion site in the right popliteal artery was described as highly stenosed.Additionally, it is likely that during the difficulty advancing, the stretching and bunching noted on the inner member and outer member occurred.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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