This is regarding malfunction of medtronic hawk s and hawk m atherectomy devices used during peripheral arteriography in this patient.Hawk m device "jammed", and failure to function.This was then replaced by a hawk s device, which was advanced through the recommended 6f sheath, but had resistance in advancing and retrieval.The crown got dislodged in the sheath, within the patient.The sheath was removed in toto and the crown was retrieved.Another similar incident also resulting in dislodging of crown within a separate patient happen the same week on monday.This is a similar concern that had resulted in class 1 recall by the fda.Fda safety report id# (b)(4).
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