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

Model Number	DBP-125SOLID145
Medical Device Problem Codes	Difficult to Remove (1528); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	02/26/2026
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 the diamondback 360 peripheral orbital atherectomy device (oad) was being used for treatment of the left peroneal artery (pt) through common femoral artery (cfa) access.While spinning, the oad made an audible sound (bogged down) and could not be retracted over the viperwire advance guide wire; it seemed the oad/crown was stuck on the viperwire.It was unknown if the oad led lights were lit when the oad stalled.Everything had to be pulled out.Ex vivo there was no physical damage observed on the oad driveshaft or viperwire.The physician attempted to rewire the peroneal artery to treat the dissection unsuccessfully - the lesion was in anterior tibial artery.There was no flow when an image was obtained in peroneal artery when the oad and viperwire were removed.During final angiogram, some flow was noted in peroneal artery but was not complete to the foot.The procedure was completed with intravascular lithotripsy (ivl) and percutaneous transluminal angioplasty (pta).The patient was stable.It was believed the oad stalled in a dissection area in peroneal artery, however, this was not confirmed.
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis was performed on the returned device.The reported orbital atherectomy device (oad) stalling was confirmed.The reported oad stuck on the guide wire could not be confirmed.The guide wire 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 reported information and the observations from the returned analysis, the investigation determined that the reported oad stalling appears to be related to circumstances of the procedure.The oad was returned with biological material accumulated on the driveshaft near the crown.The cause of the accumulation is unknown.An in-house test guide wire was able to pass through the device.Detailed analysis showed that the oad experienced a stall event during the procedure.The relationship (if any) between the stall event and the reported patient effects is unknown.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 4755, 4118, 3233, and 11 no longer apply).
Event or Problem Description
It was reported that the diamondback 360 peripheral orbital atherectomy device (oad) was being used for treatment of the left peroneal artery (pt) through common femoral artery (cfa) access.While spinning, the oad made an audible sound (bogged down) and could not be retracted over the viperwire advance guide wire; it seemed the oad/crown was stuck on the viperwire.It was unknown if the oad led lights were lit when the oad stalled.Everything had to be pulled out.Ex vivo there was no physical damage observed on the oad driveshaft or viperwire.The physician attempted to rewire the peroneal artery to treat the dissection unsuccessfully - the lesion was in anterior tibial artery.There was no flow when an image was obtained in peroneal artery when the oad and viperwire were removed.During final angiogram, some flow was noted in peroneal artery but was not complete to the foot.The procedure was completed with intravascular lithotripsy (ivl) and percutaneous transluminal angioplasty (pta).The patient was stable.It was believed the oad stalled in a dissection area in peroneal artery, however, this was not confirmed.

• 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, #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: 24682245
• Report Number: 3004742232-2026-00059
• Device Sequence Number: 18573493
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)261231(10)559646-1
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220568
• 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): 04/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 559646-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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: Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American