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	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a diamondback 360 precision coronary orbital atherectomy device (oad) was used for treatment of diffuse, long, 360-degree/heavily calcified, non-tortuous, 90% stenosed lesion in mid left anterior descending artery (lad).A non-abbott guide wire was exchanged for a viperwire advance coronary guide wire with flex tip.There was no difficulty wiring or delivering devices.There was no wire bias.Two low-speed treatments were performed.During the third treatment which was at low speed, there was no support and an unspecified guide kept on coming back a little bit.When the guide started pulling back it pulled the viperwire with it and that¿s when the oad crown crossed the lesion, jumped forward and sheared off the viperwire radiopaque spring tip.The fragment remained in distal lad.As the physician believed snaring the fragment would have been more harmful, a stent was used to pin the fragment on the artery wall in distal lad and a second stent placement was performed in mid lad to finish treating it.There were no further complications.The patient was stable and discharged as planned.The physician does not have any concerns about potential long-term risk outcomes.
Additional Manufacturer Narrative
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
It was reported that a diamondback 360 precision coronary orbital atherectomy device (oad) was used for treatment of diffuse, long, 360-degree/heavily calcified, non-tortuous, 90% stenosed lesion in mid left anterior descending artery (lad).A non-abbott guide wire was exchanged for a viperwire advance coronary guide wire with flex tip.There was no difficulty wiring or delivering devices.There was no wire bias.Two low-speed treatments were performed.During the third treatment which was at low speed, there was no support and an unspecified guide kept on coming back a little bit.When the guide started pulling back it pulled the viperwire with it and that¿s when the oad crown crossed the lesion and jumped forward and sheared off the viperwire radiopaque spring tip.The fragment remained in distal lad.As the physician believed snaring the fragment would have been more harmful a stent was used to pin the fragment on the artery wall in distal lad and a second stent placement was performed in mid lad to finish treating it.There were no further complications.The patient was stable and discharged as planned.The physician does not have any concerns about potential long-term risk outcomes.
Additional Manufacturer Narrative
Additional information: h3, h6, h11.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 device damaged by another device, 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 device damaged by another device, 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.The orbital atherectomy device referenced in b5 is filed under a separate medwatch report number.

• 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: 23336889
• Report Number: 3004742232-2025-00312
• Device Sequence Number: 9452468
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)260131(10)523845-1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 11/20/2025

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: 01/31/2026
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 523845-1
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White