At the time of this report, the cause of the patient's symptoms remains unknown.If additional information is received, a supplemental report will be submitted.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.(b)(4).
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Following an atherectomy procedure, in which viperslide was used, the patient experienced lowered blood pressure and erratic heart rhythm.The patient's breathing was also affected, and the access site became blotchy and red.Benadryl was administered for a suspected allergic reaction.The patient was transferred to the emergency room as a precaution.The patient stabilized.There were no allergies listed in the patient's medical records, and diagnosis was complicated due to language barrier.
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