Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation at 57.6cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported kink.
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Reportable based on device analysis completed on 08apr2020.It was reported that shaft kink was encountered.The target lesion was located in the proximal and middle of right coronary artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for use.However, during procedure, it was noticed that the proximal and middle of the balloon was kinked.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed a shaft detached.
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