Reportable based on the device analysis completed on 05mar2024.It was reported that leaking in the shaft occurred.A 7.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the contrast agent continued to leak out of the catheter tip while dilating.Due to this, it was confirmed that the balloon had not expanded at all.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.However, returned device analysis revealed longitudinal tear.
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