It was reported that the procedure was to treat the aorta that did not have any tortuosity or calcification.A 14 x 40 mm armada 35 balloon catheter was used and did not meet any resistance during advancement.It was inflated once to nominal pressure without issues.The balloon may have been deflated for less than 5 seconds and was fully deflated without issues.After it was deflated and removed from the anatomy, the balloon was noted to have "peeled off" (lifted off) the catheter; however, the balloon was still attached to the device.It was confirmed under fluoroscopy that no foreign material was left in the anatomy.Additionally, the device did not meet any resistance during removal.There were no adverse patient effects and 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 foreign material 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 identified no other incidents.It should be noted that the armada 35 instruction for use states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.Furthermore, the deflation time for the 14 x 40 mm armada 35 is 30 seconds.In this case, the ifu deviations do not appear to have contributed to this event.The investigation determined the foreign material attached to the proximal seal appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Attachment: user facility medwatch report number (b)(4).
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