It was reported that a tip fracture occurred.A flextome monorail cutting balloon was selected for use for a percutaneous coronary intervention procedure.Vascular access was obtained via the radial artery.The 90% stenosed, 20mmx3.0mm, concentric, de novo target lesion was located in mildly tortuous and severely calcified left anterior descending artery containing a less than 45 degree bend.The lesion was pre-dilated using a maverick balloon.Following pre-dilation, the lesion was 80% stenosed.During the procedure, the flextome cutting balloon was advanced to the lesion, however, the device was found unable to inflate.Subsequently, the device was removed slowly and smoothly with no resistance noted.The tip of the device was found to be fractured after it was removed.No fragments of the device was left inside the patient.Consequently, the procedure was completed with a different device.No complications reported and patient is stable.
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