(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.It is likely that the balloon rupture occurred due to interaction with the lesion site.The separation during removal likely occurred when removing the catheter and the ruptured balloon material caught on the introducer sheath.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 investigation determined that the reported difficulties and subsequent patient effects appear to be due 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 armada dilatation catheter was advanced to the heavily calcified anterior tibial artery lesion.Balloon inflation was performed at 15 atmospheres when the balloon ruptured circumferentially.Negative pressure was pulled, however, the balloon was unable to be retracted into the sheath.Snare removal attempts were made; however, the balloon separated at the distal end and traveled into the common femoral artery, blocking the profunda.An absolute pro stent was implanted to embed the separated balloon portion in the common femoral artery.There was no adverse patient sequela.There was no additional information provided regarding this issue.
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