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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Entrapment of Device (1212); Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 entrapment of device, device embedded in tissue or plaque, device contaminated at the user facility, medication required, surgical intervention, and unexpected medical intervention appear to be related to operational context.In this case, it is possible that the reported entrapment of device, device embedded in tissue or plaque, device contaminated at the user facility, medication required, surgical intervention, and unexpected medical intervention are related to patient anatomical morphology 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.
Event or Problem Description
It was reported that during procedure to treat highly calcified, chronic totally occluded peroneal artery through femoral artery access, the crown of the 1.25mm micro diamondback 360 peripheral orbital atherectomy device (oad) became stuck in the vessel due to calcification.The reference vessel diameter was 2.5mm.The viperwire advance guide wire was moving freely but the crown seemed wrapped/stuck in calcium.Oad removal attempts including use of glideassist, use of buddy wire with balloon to attempt crown dislodgement, external calf massage to loosen oad, and nitroglycerin/vasodilators administration were unsuccessful.Surgery was performed to completely remove the oad.The oad was observed to have plaque and calcium upon removal.The surgery was completely successful.The patient was stable.

• 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, #3008814558; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 23088732
• Report Number: 3004742232-2025-00277
• Device Sequence Number: 10502651
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)270331(10)567796-1
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 09/18/2025

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-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 567796-1
• 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: 08/26/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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: 89 YR
• Patient Sex: Female
• Patient Race: Black Or African American