Reportable based on device analysis completed on 10jan2020.It was reported that shaft kink occurred.The 92% stenosed, 14mmx2.4mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.5mm x 12mm quantum maverick balloon catheter was advanced for dilatation; however, the balloon delivery shaft was kinked.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed hypotube separation.
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