(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.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 revealed no other incidents.The armada 35 instructions for use (ifu), 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.In this case, it could not be determined if using the armada 35 off-label caused or contributed to the reported difficulties.The investigation determined that the reported difficulties appear to be related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a de novo lesion in a mildly tortuous and heavily calcified aortic artery that was 70% stenosed.A 12 x 40 mm armada 35 balloon catheter was used and met initial resistance with the anatomy.However, the balloon ruptured during its first inflation.Therefore, the device was removed and an unspecified armada 35 balloon catheter was used 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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