Reportable based on device analysis completed on (b)(6) 2022.It was reported that balloon leak and inflation problem were encountered.The stenosed target lesion was located in the iliac vein.A 12.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during the initial inflation at nominal pressure, the balloon could not be fully inflated.After removal, it was found that the balloon was leaking fluid.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed a balloon pinhole.
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