MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that following 5 low-speed treatments with the diamondback 360 precision coronary orbital atherectomy device (oad) in the heavily calcified, heavily tortuous left anterior descending artery (lad) proximal dissection of the lad was noticed along with no flow through the vessel.The oad was removed.Flow was restored when the physician started placing stents.The physician placed the first stent where the known lesion was located.At that time the flow was restored to the proximal vessel.The physician then began placing stents distal to the first stent when flow was eventually restored.A total of 5 medium-length stents were used to treat the dissection.The patient was stable.In the opinion of the physician the no flow was due to the dissection of the lad caused by the oad.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot-specific issue.Based on the information received, the investigation determined that the reported patient vascular dissection, obstruction/occlusion and unexpected medical intervention appear to be related to operational context.In this case it is possible that the reported patient vascular dissection, obstruction/occlusion and unexpected medical intervention are a result of the patient¿s disease severity and/or use techniques employed; however, since the device was not returned this could not be confirmed.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Updated: g3, g6, h2, h6 (codes 4118, 3233, and 11 no longer apply).
Event or Problem Description
It was reported that following 5 low-speed treatments with the diamondback 360 precision coronary orbital atherectomy device (oad) in the heavily calcified, heavily tortuous left anterior descending artery (lad) proximal dissection of the lad was noticed along with no flow through the vessel.The oad was removed.Flow was restored when the physician started placing stents.The physician placed the first stent where the known lesion was located.At that time the flow was restored to the proximal vessel.The physician then began placing stents distal to the first stent when flow was eventually restored.A total of 5 medium-length stents were used to treat the dissection.The patient was stable.In the opinion of the physician the no flow was due to the dissection of the lad caused by the oad.

• Brand Name: DIAMONDBACK CORONARY
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24327216
• Report Number: 3004742232-2026-00025
• Device Sequence Number: 13180353
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• UDI-Public: (01)10850026568698(17)261031(10)553787-1
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10098-01
• Device Lot Number: 553787-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male