MAUDE Adverse Event Report: Cardiovascular Systems Incorporated Diamondback Coronary; Catheter, Coronary, Atherectomy

Model Number	DBEC-125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
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 the procedure was to treat a heavily calcified lesion in right coronary artery (rca).The physician attempted to use a 1.5 rotational atherectomy device but it stalled and got stuck immediately.A diamondback 360 precision coronary orbital atherectomy device (oad) was then inserted and 4 proximal-to-distal treatments were performed on low speed.While removing the oad from the body, it was noticed that the driveshaft was fractured at the crown.The oad and the viperwire advance coronary guide wire were removed as a system.The vessel was rewired and a 3.0 non-abbott balloon was used to fully treat the calcium followed by ballooning and stent placement.There was no clinically significant delay in procedure and no adverse patient effects.The physician believed the fracture occurred due to the angulation and severity of calcification.No additional information was provided.

• 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 ; +1(651)756-2718
• MDR Report Key: 25681392
• Report Number: 3004742232-2026-00164
• Device Sequence Number: 17320366
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• UDI-Public: (01)10850026568698(17)261130(10)556701-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10098-01
• Device Lot Number: 556701-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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
• Patient Sex: Unknown