Reportable based on device analysis completed on 04-apr-2024.It was reported that balloon leakage occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified arteria cruralis.A 5.0 x 40, 135cm mustang balloon catheter was advanced for in a placed stent for dilation.During the procedure, leakage was found during expansion preventing the lesion from being fully dilated in the patient.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed a balloon pinhole located at the distal markerband.
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