It was reported that the procedure was performed to treat a lesion in the external iliac artery.A 7x40mm armada 35 balloon catheter was prepped outside the anatomy prior to use without any issues.A non-abbott stent was deployed and the balloon catheter was being used to post-dilate the stent; however, the balloon ruptured at 20 bars during the first inflation.Difficulty removing the ruptured balloon was felt.The balloon separated in multiple pieces and some of the balloon pieces were entrapped in the stent struts, but a lasso was used to successfully remove all the separated balloon pieces from the patient anatomy.There was a clinically significant delay in the procedure.No additional information was provided.
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Visual analysis and scanning electron microscopy (sem) analysis was performed on the returned device.The reported balloon rupture and separation was 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 indication of a lot specific product quality issue.The investigation determined that the reported difficulties and subsequent treatments to remove the separated balloon material were likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the stent and possibly due to over-inflation.There were no leaks reported during preparation or during use for pre-dilatation, 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.The additional damages noted to the returned unit likely occurred during the difficulties encountered while removing the ruptured/separated device from the anatomy.It should be noted that the armada 35 instruction for use (ifu) states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 15 atmospheres as indicated on the product label.For this event, the balloon was inflated to approximately 20 atmospheres which is 5 atmospheres above the rated burst pressure; however, it could not be determined if inflating the balloon above the rated burst pressure solely caused the rupture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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