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

Model Number	DBP-200MAX145
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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 that the diamondback 360 peripheral orbital atherectomy device (oad) packaging was observed to be open when it was taken off the shelf by staff for a procedure.A note was on the box indicating the packaging was opened.It was unknown why the packaging was opened.A new oad was used to complete the procedure.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported unsealed device packaging was 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 unsealed device packaging could not be determined.The oad was returned in the tray without a sterile pouch.It cannot be determined when the pouch was opened and discarded.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, 11 no longer apply.
Event or Problem Description
It was reported that the diamondback 360 peripheral orbital atherectomy device (oad) packaging was observed to be open when it was taken off the shelf by staff for a procedure.A note was on the box indicating the packaging was opened.It was unknown why the packaging was opened.A new oad was used to complete the procedure.
Event or Problem Description
It was reported that the diamondback 360 peripheral orbital atherectomy device (oad) packaging was observed to be open when it was taken off the shelf by staff for a procedure.A note was on the box indicating the packaging was opened.It was unknown why the packaging was opened.A new oad was used to complete the procedure.
Additional Manufacturer Narrative
Correction: g1.

• Brand Name: DIAMONDBACK
• 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; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 22689263
• Report Number: 3004742232-2025-00220
• Device Sequence Number: 9045262
• Product Code: MCW
• UDI-Device Identifier: 10850026568445
• UDI-Public: (01)10850026568445(17)270131(10)562524-1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 10/17/2025

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 Model Number: DBP-200MAX145
• Device Catalogue Number: 7-10057-10
• Device Lot Number: 562524-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 10/17/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/02/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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