MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE); CORONARY ATHERECTOMY DEVICE

Model Number	VPR-GW-14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The viperwire advance guide wire tip fractured in vivo.A snare was used to remove the fractured component.The patient was in stable condition and did not experience any complications as a result of this event.
Additional Manufacturer Narrative
The investigation is ongoing.A final report will be submitted once the investigation is complete.(b)(4).
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6.The viperwire advance guide wire was returned with a core fracture within the spring tip.Based on the length of the wire, there was an estimated 1.2 centimeters fractured section that was not returned.The spring tip was uncoiled and severely stretched.Scanning electron microscopic (sem) analysis of the distal core fracture face showed evidence of fatigue.It is possible the spinning crown was advanced within 10 centimeters of the spring tip which caused fatigue forces on the spring tip.However, this could not be confirmed and the exact root cause of the fracture could not be determined.The material inspection report for this guide wire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE)
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st paul, MN 55112
• MDR Report Key: 18874772
• Report Number: 3004742232-2024-00125
• Device Sequence Number: 9135717
• Product Code: MCX
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)250731(10)505801-1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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 Expiration Date: 07/31/2025
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 505801-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2024
• 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 Sex: Unknown