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

Model Number GWC-12325LG-FT

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2023

Event Type  Injury  

Event Description

Following a wire exchange for the viperwire advance guide wire the diamondback 360 coronary orbital atherectomy device (oad) was used for treatment in a 4mm, 90% stenosed, highly tortuous left circumflex artery (lcx).The oad was advanced on glideassist and then spun three times on low speed and three times on high speed.Cineangiography was checked and the oad driveshaft was fractured distal to the crown.The oad was removed and after five hours, the fractured component was successfully retrieved with a guide extension catheter.A new oad and same viperwire were used to resume atherectomy, treating with the pushing and pulling technique.The viperwire was observed to be moving abnormally.The oad was stopped.When attempting to pull on the viperwire, it could not be extracted, and it was observed to be fractured.Unsuccessful attempts were made to retrieve the fractured viperwire component.A stent was placed to pressure bond the fractured component and the procedure was completed.The patient was stable.

Manufacturer Narrative

The investigation is ongoing.A final report will be submitted once the investigation is complete.Related regulatory report 3004742232-2024-00080.Csi id: (b)(4).

Manufacturer Narrative

The viperwire advance guide wire was received for analysis.The guide wire core was fractured 316.5 from the proximal end.The distal fractured section was not returned for analysis.Scanning electron microscopy (sem) analysis was performed on the fractured face and sem identified nitinol fatigue and evidence of rotational wear on the surface of the wire near the fracture site.Bench testing has shown that excessive wear between the guide wire and tip bushing may occur due to tortuosity, tight bends, and/or buckled shape.It is hypothesized that the excessive wear led to the eventual fracture of the guide wire, although the root cause of the fracture could not be conclusively determined.Also, per the complaint details, the guide wire continued to be used for treatment with a second oad after the first oad experienced a driveshaft fracture.It is possible the driveshaft fracture event from the initial oad damaged or compromised the guide wire, contributed to the fracture.However, this could not be confirmed.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)
• Type of Device: CORONARY 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: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18527748
• MDR Text Key: 333050247
• Report Number: 3004742232-2024-00081
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491141
• UDI-Public: (01)10850000491141(17)241031(10)457058-1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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
• Device Operator: Health Professional
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-02
• Device Lot Number: 457058-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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