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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
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 and unexpected medical intervention appears to be related to user error.In this case, per reported details, the material separation is due to not maintaining adequate distance between the driveshaft and spring tip.It was reported that the oad driveshaft came in contact with the viperwire guide wire spring tip, leading to the spring tip fracturing.The diamondback 360® coronary orbital atherectomy system instruction for use (ifu), warns: ¿use fluoroscopy to monitor and maintain spacing between the driveshaft and guide wire spring tip throughout the procedure.Always keep more than 5mm of spacing between the distal end of the oad driveshaft and the proximal end of the guide wire spring tip.If the distance between the driveshaft tip and the viperwire guide wire spring tip is insufficient, the driveshaft tip may contact the guide wire spring tip and result in dislodging the guide wire spring tip.¿ 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: h6 (codes 4118, 3233, and 11 no longer apply).
Event or Problem Description
It was reported the diamondback 360 coronary orbital atherectomy device (oad) was being used to treat a heavily calcified right coronary artery (rca).After six antegrade treatments, the oad was advanced too close to the viperwire guide wire spring tip, which led to the viperwire fracturing.The fractured component was able to be snared.There were no patient complications were reported as a result of the event.The patient was in stable condition.
Event or Problem Description
It was reported the diamondback 360 coronary orbital atherectomy device (oad) was being used to treat a heavily calcified right coronary artery (rca).During the procedure, the oad was advanced too close to the viperwire guide wire spring tip, which led to the viperwire fracturing.The fractured component was able to be snared.There were no patient complications were reported as a result of the event.The patient was in stable condition.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• 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, #3008814558; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24750377
• Report Number: 3004742232-2026-00073
• Device Sequence Number: 18725009
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)270630(10)576041-1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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 Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 576041-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown