A further clinical review of this event was performed and identified the event to be mdr reportable pursuant to 21 cfr part 803.A manufacturing review could not be conducted as the lot number is unk.The investigation is inconclusive as the device was not returned.The definitive root cause could not be determined based upon the available info.It is unk if pt and/or procedural issues contributed to this event.The current ifu (instructions for use) states: warnings and precautions: do not activate the crosser recanalization system without proper irrigation.Make sure to establish proper irrigation prior to introduction into guide catheter.Always use refrigerated saline.Do not exceed 5 minutes of activation time as crosser catheter malfunction may occur.If 5 minutes of activation time is achieved, exchange for a second crosser catheter before resetting the crosser generator.When manipulating the crosser catheter, the catheter shaft may become warm to the touch.A warm feeling is normal, however, if the catheter shaft becomes hot, discontinue use immediately and withdraw from pt.Once removed from the pt, confirm that irrigation is flowing.
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