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	Foreign Body In Patient (2687)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.The production records for this product could not be reviewed and a similar complaint query could not be performed because the part number and/or lot number was not reported, and the device was not returned.Based on the information received, the investigation determined that the reported device damaged by another device, material separation and foreign body in patient resulting in unexpected medical intervention appears to be related to user error.In this case, it is possible that the reported device damaged by another device, material separation and foreign body in patient resulting in unexpected medical intervention is due to inadequate space between the oad and the guide wire spring tip.This is consistent with complaint details which state "during treatment, it was indicated the necessary space between the oad driveshaft and viperwire spring tip was not maintained." 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.¿ 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.The additional orbital atherectomy device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported a diamondback 360 coronary orbital atherectomy device (oad) was being used to treat the right coronary artery (rca).During treatment, it was indicated the necessary space between the oad driveshaft and viperwire spring tip was not maintained.After five low speed treatments, there was friction between the oad and viperwire guide wire, which led to subsequent detachment of the viperwire spring tip.Vessel predilation and a stent were used to secure the fractured component.The fractured component remained in-vivo.The procedure was completed without further complication.It was indicated there was no wire bias observed during the procedure and there was no difficulty wiring or delivering devices.The patient was discharged the day after the procedure 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: 22996248
• Report Number: 3004742232-2025-00261
• Device Sequence Number: 13115003
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)260831(10)549545-1
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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
• Report Date (Section B): 09/08/2025

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: 549545-1
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• 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