It was reported that the procedure was to treat a lesion in external iliac artery with heavy calcification and heavy tortuosity.The 5x120mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon was inflated; however, the balloon ruptured during the first inflation at 8 atmospheres (atm).Therefore, the bdc was removed from the patient.Another armada balloon was used to complete the procedure.It was noted that the device was not prepped outside the anatomy prior to use, there was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.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 other similar incidents and/or complaints from this lot.It was reported that the device was not prepared (air aspiration) outside the anatomy.It should be noted that the percutaneous transluminal angioplasty (pta) armada 35 / armada 35 ll, global, instruction for use (ifu), indicates to perform the steps to remove all air and verify the integrity of the pta catheter.Leave the catheter under negative pressure until the balloon is at the target lesion site.Then the device can be introduced the device into the vascular system.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.The investigation determined the reported complaint appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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