CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date is year valid.Health effect - suggested clinical code 4581: slow/no flow, endothelial dysfunction, and ventricular spasm.Investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that slow flow or no reflow phenomenon is a potential adverse event that may occur and/or require intervention with use of the system.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.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.Csi id: (b)(4).
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Event Description
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During an atherectomy procedure with a diamondback 360 coronary orbital atherectomy device (oad), a patient experienced an endothelial dysfunction, microvascular obstruction, and ventricular spasm.This led to a no reflow event.Medication was administered to resolve the no reflow.The patient was in stable condition.
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