BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 20159425 · Received September 6, 2024

    Report

    Report Number
    2124215-2024-55871
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 6, 2024
    Manufacturer
    FARAPULSE, INC.
    Product Code
    QZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE MERIT INQWIRE ROSEN J TIP GUIDEWIRE WAS STUCK IN THE CATHETER AFTER ABLATING THE FIRST TWO VEINS. THE PHYSICIAN PULLED THE DEVICE OUT TO INSPECT, AND NO TISSUE WAS OBSERVED. THE GUIDEWIRE WAS DISLODGED WHEN ATTEMPTING TO PULL THE WIRE FROM THE DISTAL END OF THE FARAWAVE PULSED FIELD ABLATION CATHETER AND THEREFORE, BOTH THE CATHETER AND GUIDEWIRE WERE REMOVED FROM THE BODY. SUBSEQUENTLY, THE GUIDEWIRE AND CATHETER WERE REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS. THE DEVICES WERE EXPECTED TO RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319788 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI FARAPULSE, INC. 0008021974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown