Reportable based on device analysis completed on 22dec2020.It was reported that the balloon could not cross the lesion.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 10/2.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon could not cross the lesion.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that there was a hypotube break at 68cm distal from the strain relief.
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