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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Vasoconstriction (2126); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/05/2026
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, vasoconstriction and surgical 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, vasoconstriction and surgical 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 a diamondback 360 peripheral orbital atherectomy device (oad) was being used in an attempt to treat heavily calcified, moderately tortuous, 100% stenosed posterior tibial artery (pta).Glideassist mode was used in an attempt to cross through the pedal arch to treat the pta, however, the oad became stuck in the pedal arch.Multiple attempts were made to dislodge the oad.All attempts were unsuccessful.Open endartectomy of the dorsalis pedia was performed to free the oad.The patient was in stable condition with patent dorsalis pedis.It was indicated the vessel was too small for the oad and a vasospasm occurred, which led to the oad becoming stuck.

• 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: 24682157
• Report Number: 3004742232-2026-00060
• Device Sequence Number: 9652824
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)270430(10)569836-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/24/2026

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-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 569836-1
• 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: 03/05/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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 Sex: Unknown