(b)(4).Evaluation summary: visual, dimensional and functional inspection was performed on the returned stent.The resistance with the guide wire and tear to the balloon was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported revealed no other incidents.The rx herculink elite renal and biliary stent system instructions for use instructs that prior to use, flush the guide wire lumen with normal saline until fluid exits the guide wire exit notch.The difficulties encountered appear to be related to failing to flush the guide wire lumen prior to the initial advancement and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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It was reported that the patient underwent a stenting procedure to treat a target lesion in the right renal artery.The herculink elite stent delivery system was not flushed prior to use, and when advanced over the spartacore guide wire, resistance was felt.The device was removed from the guide wire with difficulty, and the end of the guide wire kinked.In order to remove the herculink elite and maintain vessel access, the kinked end of the guide wire was cut off.The herculink was easily removed from the guide wire.The herculink elite was flushed and was advanced over the same guide wire; however, when the guide wire was cut, a burr occurred at the cut end.The burr caused a tear in the herculink elite delivery system balloon and the device was removed from the guide wire without resistance.A second herculink elite stent delivery system was then prepared, and was flushed appropriately.The device was advanced over the same cut spartacore guide wire without difficulty and the stent was successfully implanted.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
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