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

Model Number	DBP-200SOLID145
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure to treat right superficial femoral artery (sfa) using a diamondback 360 peripheral orbital atherectomy device (oad), after several treatments on low and medium speed, the device shut down due to what was believed to be dissection.The physician ensured the viperwire guidewire and oad handle were all straight, and ran the device again but the same issue occurred.It was noted that there might be a dissection the crown was getting caught in.The device was removed from the body.There was no dissection noted prior to using oad.Type a dissection was observed when the picture was taken after the oad was removed, and percutaneous transluminal angioplasty (pta) was done.The procedure was completed using non-abbott intravascular lithotripsy (ivl), pta, and use of non-abbott stents to treat dissection.The patient was stable.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• Brand Name: Diamondback Peripheral
• Common Device Name: Catheter, Peripheral, Atherectomy
• Manufacturer (Section D): Cardiovascular Systems Incorporated; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): Cardiovascular Systems Incorporated; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; +1(651)756-2718
• MDR Report Key: 50039229
• Report Number: 3004742232-2026-00184
• Device Sequence Number: 21459399
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)271231(10)595323-1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K210586
• 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,Followup
• Report Date (Section B): 09/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 595323-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 08/25/2026; 09/21/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/18/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2025
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 123 LB
• Patient Race: White