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

Model Number	GWC-12325LG-FT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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 a diamondback 360 coronary orbital atherectomy device (oad) was being used to treat a severely calcified, tortuous, 90% stenosed left circumflex artery (lcx).Eight to ten treatments were performed.The oad crown was brought back to the guide catheter and parked to move the viperwire guide wire into the left anterior descending artery (lad).During this, the viperwire spring tip fractured.It was indicated the lesion was calcified and tortuous.There was no indication as to what led to the fracture.The fractured component was able to be retrieved.The patient was in stable condition.
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 material separation appears to be related to operational context.In this case, it is possible that the material separation is due to device placement 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: d9, g3, h2, h6 (codes 4118, 3233, and 11 no longer apply).
Event or Problem Description
It was reported a diamondback 360 coronary orbital atherectomy device (oad) was being used to treat a severely calcified, tortuous, 90% stenosed left circumflex artery (lcx).Eight to ten treatments were performed.The oad crown was brought back to the guide catheter and parked to move the viperwire guide wire into the left anterior descending artery (lad).During this, the viperwire spring tip fractured.It was indicated the lesion was calcified and tortuous.There was no indication as to what led to the fracture.The fractured component was able to be retrieved.The patient was in stable condition.

• 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: 23513142
• Report Number: 3004742232-2025-00339
• Device Sequence Number: 18545067
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)251130(10)515978-1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 11/30/2025
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 515978-1
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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