(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.Review of the complaint history identified no other similar incidents from this lot.The investigation determined that the reported difficulties and subsequent patient effects were likely due to case circumstances.It is likely that the balloon rupture occurred due to interaction with the anatomy which was described as heavily calcified.The resistance and separation during removal likely occurred as the ruptured balloon material caught in the sheath.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 armada 35 was easily advanced to the non-tortuous, moderate to heavily calcified, right common iliac artery.Post dilatation of the non-abbott stent was performed one time with the armada.When the armada was being taken to rated burst pressure, the balloon burst and the armada could not be removed from the anatomy.The sheath size was up-sized to 11 french, and the armada was removed with much difficulty.During attempt to remove, a segment of the armada balloon separated.The separated piece was removed percutaneously using another balloon dilatation catheter from the left side.There was quite a bit of bleeding around the sheath access site at the femoral artery.Endarterectomy was performed and a patch was placed to treat arterial damage done by the large sheath.The patient is doing fine.No additional information was provided.
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