H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that abrupt vessel closure and vascular dissection are potential adverse events that may occur and/or require intervention with use of the system.H6 health effect - clinical code 4581: abrupt vessel closure.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.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).
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