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

Model Number	DBP-EX-125SOL145
Medical Device Problem Codes	Material Separation (1562); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was being used to treat a 70% stenosed posterior tibial artery (pt).When the oad was in vivo, it was observed that blood was coming back up into the driveshaft of the oad and exiting about four inches from the oad nosecone.The physician didn't have support to move the oad crown, so the oad was removed from the patient for assessment.Ex vivo, it was observed the outer covering of the spring coils looked disconnected from the oad nosecone, as if it had moved up.The saline sheath wasn't there to support the spring coils and blood was exiting through that spot.It was possible the sheath disconnected while entering the patient, but it was unable to be conclusively determined if that had been the case.Due to blood backing up, a new oad was used to complete the procedure.There were no patient complications as a result of the event and no clinically significant delay.The flow of saline to the tip of the oad was considered sufficient enough to avoid injury to the patient.Contrast and vasodilators were administered through the oad during the procedure.Forward saline flow did not stop for any reason during the procedure.
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
A diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was being used to treat a 70% stenosed posterior tibial artery (pt).When the oad was in vivo, it was observed that blood was coming back up into the driveshaft of the oad and exiting about four inches from the oad nosecone.The physician didn't have support to move the oad crown, so the oad was removed from the patient for assessment.Ex vivo, it was observed the outer covering of the spring coils looked disconnected from the oad nosecone, as if it had moved up.The saline sheath wasn't there to support the spring coils and blood was exiting through that spot.It was possible the sheath disconnected while entering the patient, but it was unable to be conclusively determined if that had been the case.Due to blood backing up, a new oad was used to complete the procedure.There were no patient complications as a result of the event and no clinically significant delay.The flow of saline to the tip of the oad was considered sufficient enough to avoid injury to the patient.Contrast and vasodilators were administered through the oad during the procedure.Forward saline flow did not stop for any reason during the procedure.
Additional Manufacturer Narrative
A visual inspection, and detailed analysis were performed on the returned device.The reported saline sheath separation and flow issue are 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 saline sheath separation and flow issue could not be determined.The oad was returned with the sheath separated at the nose cone.Detailed analysis showed that the sheath had been properly assembled with evidence of adhesive in the necessary locations and correct sheath depth.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: g3, g6, h2, h3, h6 h6: codes 4755, 4118, 3233, and 11 no longer apply.

• 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: 21817082
• Report Number: 3004742232-2025-00080
• Device Sequence Number: 20670300
• Product Code: MCW
• UDI-Device Identifier: 10852528005824
• UDI-Public: (01)10852528005824(17)260630(10)542793
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: DBP-EX-125SOL145
• Device Catalogue Number: DBP-EX-125SOL145
• Device Lot Number: 542793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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