Reportable based on device analysis completed on 30sep2020.It was reported that the presure could not be pushed when the balloon was inflated.The target lesion area was located in the cardiac artery.A 10/2.50 flextome cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that the pressure could not be pushed when the balloon was inflated.It was speculated that the balloon failed to inflate.The device was simply pulled out.The procedure was completed with a different device.No patient complications were reported and the patient is stable.However, device analysis revealed a balloon pinhole.
|