CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE
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Model Number DBEC-125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tachycardia (2095); Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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Investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vascular dissection and slow/no flow are potential adverse events that may occur and/or require intervention with use of the system.Health effect - suggested clinical code 4581: slow/no flow.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.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.
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Event Description
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A diamondback 360 coronary orbital atherectomy device (oad) was used to treat lesions in the left main artery (lm) and left anterior descending artery (lad).Four low speed treatments were performed before the patient went into ventricular tachycardia.The patient was shocked three times with amiodarone and xylocard.Balloon angioplasty was performed, and flow was partially restored.A stent was placed, and flow was completely restored.In the physician's opinion, the cause of the adverse event was hypothesized to be due to a dissection.
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