It was reported that the procedure was to treat a lesion located in the left anterior tibial artery that was moderately calcified.The access site was the left common femoral via 6fr sheath.Reportedly, the armada balloon catheter would not advance through the access site and the tip was bent.The device was caught/hooked onto the guide wire, and the devices could not be removed independently so the armada was removed with the guide wire, losing access site.Another armada was used to continue the procedure with no harm to the patient.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Visual, dimensional, and functional inspection were performed on the returned device.The reported kink was confirmed.The reported difficulty removing the device from the guide wire was not confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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 incidents and/or complaints from this lot.The investigation determined the reported complaint appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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