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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During treatment with an peripheral orbital atherectomy device, an embolism of plaque and matter occurred within the sheath.The sheath was removed, cleaned, and re-inserted into the patient to continue treatment.There were no patient adverse events or major delays.
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