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	11/05/2025
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 that a non-abbott wire was used to cross the lesion and then a microcatheter was used to swap it out for the viperwire advance coronary guidewire after crossing the lesion.A diamondback coronary orbital atherectomy device (oad) was used until the crown was advanced just short of the lesion.Five to six treatments were performed and it was unable to cross the lesion.Oad was removed and a non-compliant balloon was used that did not cross the lesion either.Oad was reintroduced again and it was finally able to cross on the third and fourth attempt of low speed treatments.Three more treatments were performed once the lesion was crossed to open the vessel up.There were no other issues during the atherectomy portion of the procedure, however, once the oad was removed safely, the physician tried to remove the viperwire coronary viperwire and it was lodged distally in the vessel.While trying to remove the wire it broke off, and about 12mm of distal portion of the wire remained in the vessel.Attempts were made to snare it out, but was left in-vivo as it was not worth the risk in the physician's opinion.
Event or Problem Description
It was reported that a non-abbott wire was used to cross the lesion and then a microcatheter was used to swap it out for the viperwire advance coronary guidewire after crossing the lesion.A diamondback coronary orbital atherectomy device (oad) was used until the crown was advanced just short of the lesion.Five to six treatments were performed and it was unable to cross the lesion.Oad was removed and a non-compliant balloon was used that did not cross the lesion either.Oad was reintroduced again and it was finally able to cross on the third and fourth attempt of low speed treatments.Three more treatments were performed once the lesion was crossed to open the vessel up.There were no other issues during the atherectomy portion of the procedure, however, once the oad was removed safely, the physician tried to remove the viperwire coronary viperwire and it was lodged distally in the vessel.While trying to remove the wire it broke off, and about 12mm of distal portion of the wire remained in the vessel.Attempts were made to snare it out, but was left in-vivo as it was not worth the risk in the physician's opinion.Additional information was received and the patient was stable.
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 resulting in unexpected medical intervention appears to be related to operational context.In this case, it is possible that the reported material separation and foreign body in patient resulting in unexpected medical intervention is due to patient disease state and/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 fields: b5, g3, g6, h2, h6 and h11.

• 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: 23649616
• Report Number: 3004742232-2025-00358
• Device Sequence Number: 10123395
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)251231(10)517406-2
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/23/2026

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: 12/31/2025
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 517406-2
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2023
• 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; Other
• Patient Sex: Male