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

Model Number	DBP-150SOLID145
Medical Device Problem Codes	Material Separation (1562); Insufficient Flow or Under Infusion (2182); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
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
A diamondback 360 peripheral orbital atherectomy device (oad) and viperwire peripheral guide wire were used to treat a superficial femoral artery (sfa).During the first treatment on low speed, blood was observed to be backing up in the catheter.Further inspection revealed the catheter was detached from the strain relief which prevented from saline flowing to the patient.Blood was dripping at the separation location.The catheter was reconnected to the strain relief, however, the physician elected to replace the oad to complete the procedure.The patient was stable and there were no patient adverse effects.
Event or Problem Description
A diamondback 360 peripheral orbital atherectomy device (oad) and viperwire peripheral guide wire were used to treat a superficial femoral artery (sfa).During the first treatment on low speed, blood was observed to be backing up in the catheter.Further inspection revealed the catheter was detached from the strain relief which prevented from saline flowing to the patient.Blood was dripping at the separation location.The catheter was reconnected to the strain relief, however, the physician elected to replace the oad to complete the procedure.The patient was stable and there were no patient adverse effects.
Additional Manufacturer Narrative
Correction: h6 replaced medical device problem code 2907 with 1562.A visual inspection and functional testing were performed on the returned device.The reported material separation and insufficient flow was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a historical 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, the investigation determined that the reported material separation and insufficient flow appears to be related to a potential product quality issue.Examination of the separated end of the saline sheath found it to be a clean separation.Manufacturing engineering review of the glue plug suggested a possible defect (short shot) in the overmolded glue plug.

• 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: 21800451
• Report Number: 3004742232-2025-00077
• Device Sequence Number: 8311291
• Product Code: MCW
• UDI-Device Identifier: 10850000491196
• UDI-Public: (01)10850000491196(17)260831(10)547561-1
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/22/2025

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: 08/31/2026
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: 7-10057-03
• Device Lot Number: 547561-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White