During a coronary procedure, a viperwire peripheral guide wire was mistakenly used with a diamondback coronary orbital atherectomy device (oad).When the oad was tested outside the patient, it became stuck on the guide wire.Following removal of the oad, it was observed via fluoroscopy that the tip of the wire had fractured during testing.No attempt was made to retrieve the wire fragment and it was left in the distal septal artery.The procedure was continued with non-csi atherectomy treatment and the patient status was good.
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The guide wire and oad were received at csi for analysis, and it was confirmed that a peripheral viperwire advance was used with a coronary orbital atherectomy device.There was significant resistance when attempting to remove the guide wire from the oad.The reported guide wire fracture was confirmed.Microscopic analysis identified evidence of possible fatigue and torsional forces.The cause of the fracture is likely related to the incompatible guide wire used, although the exact root cause is unknown.The root cause of the event is considered to be use not consistent with the ifu due to an incompatible guide wire being used.When tested, the oad functioned as intended.The material inspection report for this device lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements prior to distribution.Csi id: (b)(4).
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