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

Model Number	DBP-EX-200CLA145
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 during setup the diamondback 360 peripheral orbital atherectomy device (oad) and saline line were taken out of the packaging and connected to pump.The oad was not connected to patient or viperwire advance guide wire.The green start button on the pump was pressed to start saline flow through the saline tubing.The green led light was lit.The prime button on the pump was then pressed to purge air from the saline tubing but bubbles were observed inside the tubing.Closer examination of tubing revealed fluid leak from pinhole located between a saline tubing positioner and the saline bag spike.The oad and saline tubing were both replaced to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There is no indication as to what caused the pinhole as there was no damage to the oad packaging or tray indicating the damage occurred during transit or handling.
Additional Manufacturer Narrative
A visual inspection and functional testing were performed on the returned device.The reported fluid/blood leak - at setup, break - saline line at setup, air/gas in device were 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 pinhole in the saline line could not be determined.Analysis of the saline line identified a pinhole in the frosted tubing proximal to the saline line positioners, between the proximal positioner and the spike.There is leaking from this location.No other damage was found.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.
Event or Problem Description
It was reported that during setup the diamondback 360 peripheral orbital atherectomy device (oad) and saline line were taken out of the packaging and connected to pump.The oad was not connected to patient or viperwire advance guide wire.The green start button on the pump was pressed to start saline flow through the saline tubing.The green led light was lit.The prime button on the pump was then pressed to purge air from the saline tubing but bubbles were observed inside the tubing.Closer examination of tubing revealed fluid leak from pinhole located between a saline tubing positioner and the saline bag spike.The oad and saline tubing were both replaced to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There is no indication as to what caused the pinhole as there was no damage to the oad packaging or tray indicating the damage occurred during transit or handling.

• 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: 22609956
• Report Number: 3004742232-2025-00210
• Device Sequence Number: 13146472
• Product Code: MCW
• UDI-Device Identifier: 10852528005916
• UDI-Public: (01)10852528005916(17)270228(10)564838
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DBP-EX-200CLA145
• Device Catalogue Number: 7-10030-11
• Device Lot Number: 564838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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