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

Model Number GWC-12325LG-FT

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

The target treatment area was the left anterior descending artery (lad).During the first attempt to advance the diamondback 360 coronary orbital atherectomy device (oad), on glideassist, the viperwire advance guide wire was not properly secured, and the viperwire spring tip contacted the oad tip bushing.The viperwire spring tip fractured.The fractured component was successfully retrieved with a snare.A new viperwire was used to complete the procedure.The patient was stable.It was the physician's opinion the cause of the viperwire moving, resulting in the fracture was due to user handling.

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively 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)(6).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM(VIPERWIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE(VIPERWIRE)
• 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: 18038488
• MDR Text Key: 326959743
• Report Number: 3004742232-2023-00266
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491141
• UDI-Public: (01)10850000491141(17)240531(10)436228-1
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023

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 Expiration Date: 05/31/2024
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-02
• Device Lot Number: 436228-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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: 75 YR
• Patient Sex: Male