Reportable based on device analysis completed on 05-nov-2021.It was reported that tip leak and balloon inflation failure occurred.The 95% stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and mildly calcified vein side.A /6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation; however, during the first inflation, it was noticed thru fluoroscopy that the radiopaque substance was leaking near the tip part of the balloon and the pressure was unable to be applied.The procedure was completed with a different device.There were no patient injuries reported.However, returned device analysis revealed balloon pinhole.
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