Reportable based on device analysis completed on 10jan2020.It was reported that shaft kink occurred.The 95% stenosed, 14 x 3.0mm, target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for treatment.However, it was noted that the 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 shaft separation.
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