Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube and the hypotube is separated 68.3cm from the hub.Microscopic examination revealed no additional damages.There is contrast present in the inflation lumen and balloon.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
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Reportable based on device analysis completed on 02-jan-2019.It was reported that shaft kink occurred.The 93% stenosed, 20x1.5mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilation; however, it was noted that the shaft was kinked 65cm away from the physician's hands.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube separation.
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