Visual analysis was performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty removing could not be tested due to the condition of the returned unit.It should be noted that the armada 35 instruction 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.In this case, there is no indication that using the armada 35 off-label caused or contributed to the reported balloon rupture.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 identified no indication of a lot specific product quality issue.The investigation determined that the reported difficulties were likely due to circumstances of the procedure.It is likely that the balloon rupture occurred due to interaction with the heavily calcified lesion.The scratches noted at the rupture site further indicate that the balloon likely interacted with calcification.There were no leaks noted during preparation indicating that the damage was not pre-existing.Additionally, the radial tear/separation of the balloon material likely occurred as the balloon was being withdrawn into the introducer sheath due to the ruptured balloon material catching on the distal end of the sheath which likely caused the reported difficulty removing.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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