Analysis/device evaluation: upon receipt, visual inspection revealed a longitudinal rupture in the balloon material at the distal marker band extending approximately 22mm in length to the middle of the balloon.The distal and proximal ends of the longitudinal rupture were perpendicular to the length of the balloon, creating a wide "u" shape.The distal and proximal curves of the "u" are jagged in nature.Functional testing confirmed the balloon was not able to maintain pressure.A device history record review was not able to be performed, as the lot number was not provided by the user facility.Conclusion: returned product analysis was able to confirm a longitudinal rupture in the balloon material, which was unable to maintain pressure.Based on the information provided and analysis results, a definitive root cause was not able to be determined.It should be noted the in stent lesion in the common femoral artery, not an approved indication for use, was not predilated prior to inflating the lutonix dcb catheter and may have contributed to the event.
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It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 6 atmospheres (atms) while treating the in-stent target lesion of the distal left common iliac artery.The health care professional (hcp) used a contralateral approach to gain patient access.The hcp did not predilate the in-stent target lesion.The stent was intact and did not appear to be fractured.The hcp reportedly advanced the lutonix dcb to the target lesion in the zilver ptx stent, and inflated the balloon to 6 atms.After the lutonix dcb allegedly ruptured, reportedly it was removed in its entirety without difficulty.The hcp completed the procedure with another lutonix dcb.In the opinion of the hcp, the inflation within the zilver stent was related to the nature of the rupture.The lutonix dcb was returned for evaluation.No adverse patient outcomes were reported.
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