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

Model Number	DBP-125SOLID145
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
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.The additional viperwire guide wire referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that after the use of diamondback peripheral orbital atherectomy device (oad), during removal of the oad over viperwire guidewire, the guidewire became stuck in the device.The oad and guidewire were removed together, causing a delay in the procedure due to the physician needing to attempt to cross the lesion again with a new wire, which was unsuccessful.Due to not being able to re-cross the lesion, the procedure was aborted without fully treating the patient.It is unknown how many treatments were performed prior to oad removal.According to the physician, the delay in procedure was considered to be clinically significant to the patient due to the guidewire being removed and the inability to cross the lesion again with another wire as this led to the procedure not being completed, leaving a significant blockage.In the opinion of the physician, the aborted procedure was considered to be clinically significant to the patient as the blockage was not fully treated resulting in need for a second procedure on the patient that would not have been necessary had the wire not been removed.The patient has a follow-up procedure planned and was stable.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis and detailed analysis were performed on the returned device.The reported stuck guide wire was confirmed.A corrective and preventative actions (capa) review was performed and revealed no indication of a product quality issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported stuck guide wire appears to be related to operational context.There is dried biological material on the crown area.The guide wire was removed with significant resistance due to the shipping damage and biological material accumulation.The cause of the biological material accumulation is unknown.There was no damage or abnormalities identified 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.Updated fields: b5, b7, g3, g6, h2, h3, h6 (component code, type of investigation, investigation findings and investigation conclusions), h11.
Event or Problem Description
It was reported that after the use of diamondback 360 peripheral orbital atherectomy device (oad), during removal of the oad over viperwire guidewire, the guidewire became stuck in the device.The oad and guidewire were removed together, causing a delay in the procedure due to the physician needing to attempt to cross the lesion again with a new wire, which was unsuccessful.Due to not being able to re-cross the lesion, the procedure was aborted without fully treating the patient.It is unknown how many treatments were performed prior to oad removal.According to the physician, the delay in procedure was considered to be clinically significant to the patient due to the guidewire being removed and the inability to cross the lesion again with another wire as this led to the procedure not being completed, leaving a significant blockage.In the opinion of the physician, the aborted procedure considered to be clinically significant to the patient as the blockage was not fully treated resulting in need for a second procedure on the patient that would not have been necessary had the wire not been removed.The patient has a follow-up procedure planned and was stable.Additional information was received and the lesion was 85% stenosed, moderately calcified, non-tortuous proximal left anterior tibial (at) artery.

• 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: 23031027
• Report Number: 3004742232-2025-00266
• Device Sequence Number: 9428060
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)260531(10)538485-1
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/13/2025

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 Expiration Date: 05/31/2026
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 538485-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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