(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: visual and functional inspection was performed on the returned device.The reported leak 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 of the reported lot revealed no other incidents.The investigation determined that the leak appears to be related to a potential product quality issue.It should be noted that the armada 18 otw instruction for use (ifu) states: do not use if the device is damaged.In this case, continuing to use the device did not contribute to the leak.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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It was reported that the procedure was to treat a lesion with mild calcification in the superficial femoral artery (sfa).During preparation of the 5.5 x 200 mm armada 18 balloon catheter, some air bubbles were observed, but the armada 18 was advanced in the vessel.When the balloon was pressurized to nominal pressure a leak was observed at the hub.The balloon catheter was removed and exchanged for a new armada 18 to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effect.No additional information was provided.
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