Reportable based on device analysis completed on (b)(6) 2018.It was reported that shaft damage occurred.The target lesion was located in a coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was selected for use; however, the shaft malfunctioned.The procedure was completed with another of the same device.No patient complications were reported and the patients status was stable.However, returned device analysis revealed shaft detachment.Device evaluated by manufacturer: 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 whole device.The hypotube is separated 65.2cm from the hub.Microscopic examination did not reveal any damages.There is contrast present on the balloon and the balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
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