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	04/15/2026
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 fibrocalcific obtuse marginal (om) 2.It was indicated an unspecified balloon crossed the lesion but did not yield to dilation.Three to four antegrade treatments were performed with short backward movement to re-advance the oad.During the procedure, the viperwire guide wire fractured.There was no indication as to what led to the fracture.The fractured tip remained in-vivo in the far distal vessel and was not retrieved.There were no patient complications as a result of the event.The patient was in stable condition.The date of the procedure is an estimate.
Event or Problem Description
Additional information was received indicating there was no wire bias observed.There was no difficulty wiring or delivering devices.The physician had no significant concerns regarding long-term risk outcomes for the patient.No additional information was provided.
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 and foreign body in patient appears to be related to operational context.In this case, it is possible that the reported material separation and foreign body in patient is due to device placement and/or use techniques employed; however, since the device was not returned this could not be confirmed.The reported patient effect of foreign body in patient is listed in the diamondback 360 coronary precision orbital atherectomy device instructions for use as a known potential patient effect associated with the use of the device.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.B6 correction: date added h6 correction: medical device problem code 2915 was removed.

• 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; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; +1(651)756-2718
• MDR Report Key: 25126609
• Report Number: 3004742232-2026-00107
• Device Sequence Number: 8834004
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)271031(10)588608-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 588608-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2025
• 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: Other
• Patient Sex: Unknown