CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE
|
Back to Search Results |
|
Model Number DBEC-125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 02/13/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
H6 health effect - clinical code 4581: slow/no flow h6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vascular dissection and slow flow or no reflow phenomenon are potential adverse events 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.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).
|
|
Event Description
|
Following atherectomy using a diamondback 360 coronary orbital atherectomy device (oad), angiographic imaging observed a major dissection in the left main coronary artery.In addition, side branch occlusion was observed.The clinical event committee reviewed the images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed.No further information is available.
|
|
Search Alerts/Recalls
|
|
|