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	Foreign Body In Patient (2687)
Date of Event	01/01/2026
Type of Reportable Event	Death
Event or Problem Description
User facility medwatch report received that states "the procedure began as a diagnostic left heart cath.During the attempted orbital atherectomy of the circumflex, the diamondback catheter was unable to cross the lesion.A second attempt resulted in the burr becoming stuck, and the viper wire appeared sheared.Imaging suggested the device had become extravascular with suspected circumflex perforation.Outcome attributed to adverse event: death" the dates of event and patient expiration will be estimated as 01/01/2026.
Additional Manufacturer Narrative
B2, b3: the dates of event and patient expiration will be estimated as 01/01/2026.H10: medsun report.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The orbital atherectomy device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
User facility medwatch report received that states "the procedure began as a diagnostic left heart cath.During the attempted orbital atherectomy of the circumflex, the diamondback catheter was unable to cross the lesion.A second attempt resulted in the burr becoming stuck, and the viper wire appeared sheared.Imaging suggested the device had become extravascular with suspected circumflex perforation.Outcome attributed to adverse event: death".The dates of event and patient expiration will be estimated as (b)(6) 2026.
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, foreign body in patient and death appear to be related to operational context.In this case, it is possible that the reported material separation, foreign body in patient and death was due to patient disease state and/or use techniques employed; however, since the device was not returned this cannot 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, g6, h2, h3, h6 (codes 4118, 3233, and 11 no longer apply) h10: medsun report ((b)(4)).The orbital atherectomy device referenced in b5 is filed under a separate medwatch report number (3004742232-2026-00034).

• 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: 24401271
• Report Number: 3004742232-2026-00033
• Device Sequence Number: 8269793
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)270531(10)574098-1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 574098-1
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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: Death
• Patient Age: 65 YR
• Patient Sex: Female