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

Model Number	DBP-150SOLID145
Medical Device Problem Codes	Break (1069); Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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 the diamondback 360 peripheral orbital atherectomy device (oad) was prepped correctly and when the physician attempted the first treatment in the superficial femoral artery (sfa), it was observed the oad was not functioning as intended.The guide wire brake appeared defective.When engaged, it was still loose on the viperwire guide wire.A new oad was used to complete the procedure.
Event or Problem Description
It was reported the diamondback 360 peripheral orbital atherectomy device (oad) was prepped correctly and when the physician attempted the first treatment in the superficial femoral artery (sfa), it was observed the oad was not functioning as intended.The guide wire brake appeared defective.When engaged, it was still loose on the viperwire guide wire.A new oad was used to complete the procedure.
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis was performed on the returned device.The reported guide wire brake issues were not confirmed.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, a definitive cause for the reported guide wire brake issues could not be determined.During analysis, the guide wire brake functioned as intended and held the guide wire firmly.There was no damage to the oad including the brake assembly that would have contributed to the reported complaint.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.

• 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: 21764470
• Report Number: 3004742232-2025-00071
• Device Sequence Number: 8611232
• Product Code: MCW
• UDI-Device Identifier: 10850000491196
• UDI-Public: (01)10850000491196(17)260630(10)543887-1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: 7-10057-03
• Device Lot Number: 543887-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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