Reportable based on device analysis completed on 15oct2021.It was reported that balloon leak occurred.Vascular access was obtained via the femoral artery.The 10x2cm target lesion was located in the iliac vein.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilation.During inflation, a leak was noticed in the distal part of the balloon.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed balloon pinhole.
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