Reportable based on device analysis completed on 30nov2023.It was reported that balloon issues occurred.The 75% stenosed target lesion was located in the moderately calcified and moderately tortuous internal arteriovenous fistula.A 5.0x40, 40cm gladiator elite balloon catheter selected for use.However, during preparation, the balloon was found leaking with liquid when it was pressurized, and balloon could not be dilated.A mark of damage was noted in the balloon.The procedure was completed with another balloon catheter.No patient complications were reported, and patient's status was stable.However, device analysis revealed a balloon tear.
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