(b)(4).The two armada 18 devices were filed under separate medwatch reports.Evaluation summary: visual and functional inspections and scanning electron microscopy (sem) analysis were performed on the returned device.The physical property issue was not confirmed; however, a balloon rupture 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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determine that the balloon rupture was due to circumstances during the procedure.
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It was reported the complex procedure was to treat a lesion with heavy calcification and restenosis in the left distal superficial femoral artery (sfa).The armada 14 was found defective during unpacking and was not used.Two different armada 18 balloon catheters (4.0/200mm, 4.0/120mm) were advanced to the lesion, but both balloons ruptured at 12 atmospheres (atm).Both catheters met resistance during advancement to the lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.The armada 14 reported as defective prior to use, may have entered the patient based on blood found on the returned device.Return device analysis of the armada 14 revealed a pinhole in the balloon.
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