MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number	GWC-12325LG-FT
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
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.Also, it is unknown if the physician spun too close to the spring tip.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.
Event or Problem Description
User facility medwatch report received that states viper wire (from the orbital atherectomy system- diamondback device) fractured and sheared off into the vessel and remained in obtuse marginal artery.There is distal tip detachment of viperwire, there was no option of retrieving it due to severe stenosis in proximal vessel and distal location of the wire tip.We decided to treat by placement of des [drug-eluting stent] and trapping the wire beyond it.Additional information received on 07/31/2025: the target lesion was severely calcified distal obtuse marginal artery (om) which was accessed through radial artery.Four atherectomy treatments were performed prior to the viperwire fracture.There is no indication as to how the fracture occurred but the monitor technician (rt) believes the physician had the oad crown too close to the viperwire spring tip.The oad crown did not jump prior to the fracture.There was no wire bias.The fragment left in the patient was approximately 30mm long (radiopaque tip).The physician stented the fragment in place due to being too distal and too difficult to try to reach.The vessel was primarily wired with non-abbott guide wire which was exchanged for the viperwire.There was no difficulty wiring or delivering devices.The patient was stable after the procedure.The physician does not have any concerns about potential long-term risk outcomes.

• 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: 22811333
• Report Number: 3004742232-2025-00238
• Device Sequence Number: 7733545
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)261130(10)558783-3
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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 Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 558783-3
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American