The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.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.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vessel perforation is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).
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The diamondback 360 coronary orbital atherectomy device was used for a high speed treatment, that resulted in a perforation.A non-csi stent was used to treat perforation.The oad was discarded.In the physician's opinion, the oad contributed to perforation in the patient.
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