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

Model Number	GWC-12325LG-FT
Medical Device Problem Codes	Material Separation (1562); Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2025
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.
Event or Problem Description
It was reported that the diamondback 360 coronary orbital atherectomy device (oad) and the viperwire advance coronary guide wire with flex tip were used for treatment of mildly tortuous lesion in circumflex artery (cfx) obtuse marginal (om) from the first om through right femoral artery access with 6fr sheath.The vessel was primary wired with unspecified guide wire which was exchanged for the viperwire.There was some wire bias and getting the wire was difficult initially.Several unspecified support catheters were needed to traverse the anatomy.At the end of the procedure following three low-speed treatments and one high-speed treatment the distal radiopaque portion of the viperwire tip was sheared off.The oad crown jumped during the third treatment, but did not make contact with the viperwire spring tip.The operator suspected the interaction with the catheter was the cause of the viperwire fracture.The tip of the viperwire was not retrieved, since this occurred toward the end of the procedure.The tip was stented to the wall without any concern for long-term complications.
Event or Problem Description
It was reported that the diamondback 360 coronary orbital atherectomy device (oad) and the viperwire advance coronary guide wire with flex tip were used for treatment of mildly tortuous lesion in circumflex artery (cfx) obtuse marginal (om) from the first om through right femoral artery access with 6fr sheath.The vessel was primary wired with unspecified guide wire which was exchanged for the viperwire.There was some wire bias and getting the wire was difficult initially.Several unspecified support catheters were needed to traverse the anatomy.At the end of the procedure following three low-speed treatments and one high-speed treatment the distal radiopaque portion of the viperwire tip was sheared off.The oad crown jumped during the third treatment, but did not make contact with the viperwire spring tip.The operator suspected the interaction with the catheter was the cause of the viperwire fracture.The tip of the viperwire was not retrieved, since this occurred toward the end of the procedure.The tip was stented to the wall without any concern for long-term complications.Additional information was received indicating the oad crown jumped forward.The operator was not advancing against resistance.There was difficulty advancing the viperwire initially.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported device damaged by another device, material separation, difficult to advance and foreign body in patient resulting in unexpected medical intervention appears to be related to operational context.In this case, it is possible that the reported device damaged by another device, material separation, difficult to advance and foreign body in patient resulting in unexpected medical intervention is due to device placement and/or use techniques employed; however, since the device was not returned this could not be confirmed.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: b5, g3, g6, h2, h6 h6: code 2920 added, codes 4118, 3233, and 11 no longer apply.

• Brand Name: DIAMONDBACK CORONARY
• Common Device Name: CATHETER, CORONARY, 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: 22373060
• Report Number: 3004742232-2025-00185
• Device Sequence Number: 18122432
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)260831(10)545343-1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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): 08/08/2025

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: 08/31/2026
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 545343-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: Required Intervention
• Patient Sex: Unknown