Reportable based on device analysis completed on 09-oct-2018.It was reported that shaft damage occurred.The target lesion was located in a coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was selected for use.During preparation, the balloon was found to be failed out of the shaft.No patient complications were reported.However, returned device analysis revealed shaft detached.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 the hypotube is separated 83.8cm from the hub.There are multiple kinks along the whole device.Microscopic examination revealed no damages and the balloon is still tightly folded.There is blood present on the balloon folds and in the guidewire lumen.Although it was reported that the device was not used, the presence of blood on the balloon and in the guidewire lumen is indicative of handling beyond simply prepping the device, as was reported.Inspection of the remainder of the device presented no other damage or irregularities.The separated hypotube appeared to be kinked prior to separation.
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