(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.The armada 35 instruction for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture.In this case, it is likely that the balloon rupture was the result of inflating the balloon twice above the rated burst pressure (rbp).Based on the information provided, the reported balloon rupture, material separation and swelling appear to be due to use error.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 performed to treat a re-stenosed lesion in a fistula vein that was moderately tortuous and 80% stenosed that was treated eight months prior.An unspecified 6 french sheath and a 035 non-abbott guide wire were used with a 6x60mm armada 35 percutaneous transluminal angioplasty (pta) catheter.The pta balloon was inflated twice to 20 atmospheres when it ruptured.The pta catheter was removed, and the procedure was complete.Three days later, the patient came back with a swollen hand.Echocardiography was performed and it was determined that this swelling was due to a portion of the armada balloon catheter that had separated in the previous procedure and was still in the treated area of the fistula vein.A small surgical incision was made in the fistula area to remove the separated portion, and the patient was fine.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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