The oad and guide wire were returned to csi for analysis.A visual examination of the driveshaft and crown area confirmed that the driveshaft was fractured.When the control knob was in the forward position damage was observed near the nose cone.The fragment was returned to csi, however was lost during analysis and could not be examined further.The returned guide wire was able to pass through the remaining driveshaft and handle assembly without issue.Scanning electron microscopy analysis of the fractured filars showed evidence of fatigue which is an indication that the driveshaft was spun in a high stress environment.Review of the device data log identified four stall events.At the conclusion of the device analysis investigation, the report that the driveshaft fractured was confirmed.It is possible that the stall events were related to spinning the device through a difficult area, which would have contributed to the elevated stress levels and eventual driveshaft fracture, however the root cause of the fracture remains undetermined.The device history record for this oad 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 csi id: (b)(4).
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