It was reported that the procedure was performed to treat a moderately calcified, mildly tortuous tibial artery that was 75% stenosed.The 3.0x12mm armada 14 balloon dilatation catheter was advanced over a command es guidewire.During inflation, the balloon did not open to its complete profile and a leak was observed from the hub.The device was replaced with a 3.0x200mm armada 14 balloon to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Visual, functional and scanning electron microscopy (sem) analysis was performed on the returned device.The reported inflation issue and leak were 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 inflation issue and leak were due to a tear noted to the inner member.Although a cause for the tear could not be determined, there was no leak noted during preparation for use indicating that the damage was not pre-existing.Additionally, based on the evaluation of the returned unit and sem analysis, the inner member damage may be attributed to mechanical damage and may suggest that an object was inserted into the inflation port; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
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