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-14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2022

Event Type  Injury  

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).

Event Description

Following treatment performed in the posterior tibial artery with a diamondback 360 exchangeable orbital atherectomy device (oad) for peripheral artery disease rutherford grade iv, difficulty was experienced removing the oad.Glideassist was activated.The oad became stuck on the viperwire advance guide wire.The tip of the viperwire fractured.The tip fragment was unable to be removed from the plantar arch and remained in vivo.The procedure was completed without further issue.

Manufacturer Narrative

The viperwire advance guide was returned to csi for analysis engaged in the oad.The tip of the guide wire was not received for analysis.Visual examination confirmed the guide wire was fractured.Scanning electron microscopic analysis identified evidence of ductile torsion at the fracture site.However, the root cause of the fracture could not be confirmed.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: (b)(4).

• 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 15771459
• MDR Text Key: 303422841
• Report Number: 3004742232-2022-00244
• Device Sequence Number: 1
• Product Code: MCW
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 436978-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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