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.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.(b)(4).
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Slow flow occurred following use of the orbital atherectomy device (oad).Nitroglycerin and nicardipine were administered, and an aspiration catheter was used to restore flow.The patient was discharged home following the procedure and was in normal condition.In the opinion of the physician, the cause of the slow flow event was small vessel anatomy and atherectomy.
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