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

Model Number VPR-GW-14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2022

Event Type  Injury  

Event Description

A diamondback 360 peripheral exchangeable orbital atherectomy device (oad) was used to treat a 5mm, calcified lesion in the mid popliteal.There was a previously placed stent in the distal side of the popliteal.The viperwire advance guide wire was placed in the distal side of the stent.The oad was used to begin treatment of the mid popliteal.After two or three treatments, the oad was advanced too close to the viperwire and fractured the spring tip, as the viperwire was unable to be advanced more distally.The spring tip was snared.A new viperwire and non-csi devices were used to complete the procedure without further complication.

Manufacturer Narrative

The viperwire advance guide wire was returned with a fracture within the spring tip.Scanning electronic micrscopic imaging showed evidence of fatigue.The root cause of the event was determined to be due to use not consistent with the ifu.The peripheral ifu states: make sure there is a minimum of 10cm between the guide wire spring tip and the distal end of the shaft.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 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE)
• Type of Device: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE)
• 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: 16113825
• MDR Text Key: 306818067
• Report Number: 3004742232-2023-00003
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)240731(10)449185-1
• 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
• Report Date: 01/06/2023

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-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 449185-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/06/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White