It was reported that the patient came in due to a stroke and the procedure was to treat a mildly calcified vessel in the left carotid artery.Pre-dilatation was performed with a 4.0x40mm armada balloon without issue.Thrombectomy was performed.The 6.0x40mm armada percutaneous transluminal angioplasty (pta) catheter was prepared (air aspiration) outside the anatomy prior to use without any issues.There was no resistance during advancement through a telescoping catheter.However, the armada was inflated once to nominal pressure and the balloon ruptured.It was noted that when removing the balloon, there was resistance noted as the balloon would not pull back into the catheter.The balloon and catheter were then proceeded to be pulled out together.The patient had prior stents in the iliacs.There was resistance felt as the balloon was being pulled out through the iliacs and the tip separated.The tip was left in the patient free floating in the aorta around the level of the renal artery.There was no clinically significant delay in the procedure.No additional information was provided.
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H6: device code 1494- indication for use.Visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The difficulty removing was not tested due to the condition of the device.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 and/or complaints reported from this lot.It should be noted that the armada 35 instructions 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.¿ the investigation determined that the reported difficulties resulting in foreign body in patient were likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the anatomy calcification.There were no leaks reported during preparation, suggesting that the damage was not pre-existing.In addition, the resistance noted during removal and radial separation of the balloon material was likely the result of the ruptured balloon material catching on the introducer sheath or anatomy during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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