Reportable based on device analysis completed on 21-nov-2018.It was reported that shaft kink occurred.The target lesion was located in a coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for treatment.However, it was noted that the catheter was kinked.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 shaft detached/separated.Device evaluated by manufacturer: the returned product consisted of the proximal portion of the quantum maverick balloon catheter.Only the hub and 65.3cm of the hypotube were returned for analysis.Portion of the hypotube, the distal shaft, balloon, markerbands and tip were not returned for analysis.The hypotube was visually examined.There were numerous hypotube kinks throughout the returned portion of the returned device.There was a complete hypotube separation 65.3cm distal of the strain relief.The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation.
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