It was reported that the procedure was to treat a 90% stenosed, heavily calcified and mildly tortuous vessel in the common femoral artery.The emboshield nav 6 was prepared per instructions for use (ifu) and the placing of the filter and the procedure went very well.However, upon removal, the captured filter that was already inside the retrieval catheter could not retract through the sheath (guiding catheter).The physician used more force to retract it and was finally able to remove the retrieval catheter together with the barewire.It was then noted that the retrieval catheter was kinked at the rx guide wire exit port.There was no adverse patient effect 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 difficult to remove was not confirmed due to the condition of the returned device.The damage to the retrieval catheter 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 revealed no other complaints reported from this lot.It should be noted that the emboshield nav 6 instructions for use states: ¿if significant resistance is felt, retract the guide catheter or sheath and the retrieval catheter together.¿ although it was reported that extra force was used to remove the retrieval catheter, the excess force seemed to be a reasonable clinical response to the difficulties.The investigation determined that the reported difficulties were related to circumstances of the procedure.The difficulty removing the retrieval catheter into the guide catheter was likely due to the kink noted on the retrieval catheter at the exit port.The kink to the retrieval catheter likely occurred during positioning and retrieval of the filtration element.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.
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