Returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.There were numerous hypotube kinks throughout the device.There was a complete hypotube separation 82.5cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Inspection of the remainder of the device presented no other damage or irregularities.
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Reportable based on device analysis completed on 09jul2019.It was reported that shaft kinked occurred.The target lesion was located in the left coronary artery.During the procedure, a 3.75mm x 12mm quantum was noted to have a shaft kink.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed a hypotube break.
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