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

Model Number VPR-GW-FLEX14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2022

Event Type  Injury  

Event Description

Treatments in the heavily calcified superficial femoral artery were performed on low speed and high speed.During removal, the tip of the viperwire advance guide wire became fractured.The fractured tip was successfully snared.The patient was stable.

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Manufacturer Narrative

The guide wire was returned to csi with a fracture within the spring tip.Scanning electron microscopic analysis revealed evidence of a ductile torsional failure.The reported event was confirmed, however, the root cause was unable to be determined.The material inspection report for this guidewire 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: 12524.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE)
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)
• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16241131
• MDR Text Key: 308097369
• Report Number: 3004742232-2023-00021
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)240831(10)449199-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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
• Device Operator: Health Professional
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 449199-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention