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

Model Number GWC-12325LG-FT

Device Problems Unintended System Motion (1430); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2024

Event Type  Injury  

Manufacturer Narrative

D10: unknown part/model number and unknown lot number.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.The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.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.Csi id: 13887 and 13911.

Event Description

During the treatment of a 90% stenosed lesion in left anterior descending (lad) vessel, while the orbital atherectomy system (oas) was being used at low speed in the pushing direction, the crown jumped in the spring tip section of the viperwire advance guidewire which led to spring tip fracture.A non-abbott micro snare was used to retrieve the fractured viperwire guidewire from the patient's body.Percutaneous coronary intervention (pci) was completed successfully without any complications to the patient.After retrieval of the fractured viperwire, the procedure was completed with a balloon and a stent.The fractured viperwire was discarded.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE)
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old highway 8 nw; st. paul 55112
• MDR Report Key: 18726919
• MDR Text Key: 335709793
• Report Number: 3004742232-2024-00107
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

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: 470337-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2023
• 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
• Treatment: UNKNOWN CORONARY OAD
• Patient Outcome(s): Required Intervention