Patient identifier: (b)(6).Returned product consisted of a quantum maverick balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 50.3cm from the hub and appears to have been kinked prior to inflation.Microscopic examination revealed damage to the tip.There is contrast present in the inflation lumen and balloon.There is blood present in the guide wire lumen and 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 08-apr-2019.It was reported that shaft kink occurred.The 93% stenosed, 2.75x11mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the balloon delivery shaft was kinked at 55cm from the physician's hand.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.However, returned device analysis revealed shaft break.
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