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

Model Number	DBP-125SOLID145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 1.25 micro solid diamondback 360 peripheral orbital atherectomy device (oad) was used for proximal-to-distal treatment of lesion in tibial artery through femoral artery access.Following the first treatment, angiographic images showed a particle separated from the oad crown.Upon oad removal, the crown was observed detached.The fragment was left in one of the tibial vessels as there was flow to other vessels.No attempts to snare the fragment was made.The procedure was aborted.The patient was stable and discharged the same day.There were no future plans to remove the fragment.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection, functional testing, and detailed analysis were performed on the returned device.The reported crown separation is 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 crown separation could not be determined.Analysis of the driveshaft crown bond location found evidence of residual solder, indicating that the crown had been sufficiently bonded during manufacturing.Detailed analysis of the device showed that there had been longer than recommended spin times as well as 4 device stall events.This may have contributed to the crown separation; however 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.Updated: b5, g3, g6, h2, h3, h6, correction: h6: 2687 h6: codes 4438, 4755, 4118, 3233, and 11 no longer apply.
Event or Problem Description
It was reported that the 1.25 micro solid diamondback 360 peripheral orbital atherectomy device (oad) was used for proximal-to-distal treatment of lesion in tibial artery through femoral artery access.Following the first treatment, angiographic images showed a particle separated from the oad crown.Upon oad removal, the crown was observed detached.The fragment size was unknown.It was unknown if the driveshaft fractured.The fragment was left in one of the tibial vessels as there was flow to other vessels.No attempts to snare the fragment was made.The procedure was aborted.The patient was stable and discharged the same day.There were no future plans to remove the fragment.

• 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: 21950634
• Report Number: 3004742232-2025-00123
• Device Sequence Number: 18342909
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)261031(10)553034-1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/06/2025

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-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 553034-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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 Sex: Unknown