BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 23693879 · Received December 2, 2025

    Report

    Report Number
    2124215-2025-88009
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043193
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED WITH AN UPDATE TO SECTION: B5 DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIFFICULTY IRRIGATING THE DEVICE AND A THROMBUS OCCURRED. A PULSE FIELD ABLATION (PFA) PROCEDURE FOR ATRIAL FIBRILLATION WAS PERFORMED USING FARAWAVE NAV CATHETERS. A 31MM FARAWAVE NAV CATHETER WAS LOADED ONTO AN UNKNOWN GUIDEWIRE AND THE FARAWAVE NAV CATHETER WAS ADVANCED INTO POSITION IN THE LEFT ATRIUM. MULTIPLE 301 ERRORS OCCURRED INDICATING PRE PULSE TEST FAILURE. THE FARAWAVE NAV CATHETER WAS REMOVED AND EXCHANGED FOR A NEW FARAWAVE NAV CATHETER. THE NEW FARAWAVE NAV CATHETER WAS ADVANCED INTO THE LEFT ATRIUM AND A 201 ERROR MAIN POST FAILURE OCCURRED WHICH INDICATED A POWER ON SELF TEST FAILURE. IT WAS OBSERVED THE IRRIGATION FLOW RATE FOR THE CATHETER WAS APPROXIMATELY ONE DRIP SALINE PER 30 SECONDS. THE FARAWAVE NAV CATHETER REMAINED IN THE LEFT ATRIUM WHILE THE IRRIGATION PUMP WAS EXCHANGED FOR AN IRRIGATION PUMP WITH AN IMPROVED IRRIGATION FLOW RATE OF 2ML PER HOUR. A THROMBUS WAS OBSERVED ON THE LUMEN OF THE FARAWAVE NAV CATHETER VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE FARAWAVE NAV CATHETER WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD FARAWAVE NAV CATHETER. THE PATIENT FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A THROMBUS OCCURRED. A PULSE FIELD ABLATION (PFA) PROCEDURE FOR ATRIAL FIBRILLATION WAS PERFORMED USING FARAWAVE NAV CATHETERS. A 31MM FARAWAVE NAV CATHETER WAS LOADED ONTO AN UNKNOWN GUIDEWIRE AND THE FARAWAVE NAV CATHETER WAS ADVANCED INTO POSITION IN THE LEFT ATRIUM. MULTIPLE 301 ERRORS OCCURRED WHICH DISPLAY AT THE BEGINNING OF ABLATION IF THE PRE PULSE TEST FAILS. THE FARAWAVE NAV CATHETER WAS REMOVED AND EXCHANGED FOR A NEW FARAWAVE NAV CATHETER. THE NEW FARAWAVE NAV CATHETER WAS ADVANCED INTO THE LEFT ATRIUM AND A 201 ERROR MAIN POST FAILURE OCCURRED WHICH INDICATED A POWER ON SELF TEST FAILURE. IT WAS OBSERVED THE IRRIGATION FLOW RATE FOR THE CATHETER WAS APPROXIMATELY ONE DRIP SALINE PER 30 SECONDS. THE FARAWAVE NAV CATHETER REMAINED IN THE LEFT ATRIUM WHILE THE IRRIGATION PUMP WAS EXCHANGED FOR AN IRRIGATION PUMP WITH AN IMPROVED IRRIGATION FLOW RATE OF 2ML PER HOUR. A THROMBUS WAS OBSERVED ON THE LUMEN OF THE FARAWAVE NAV CATHETER VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE FARAWAVE NAV CATHETER WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD FARAWAVE NAV CATHETER. THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THE THROMBUS REMAINED ATTACHED TO THE FARAWAVE NAV CATHETER WHEN THE DEVICE WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959312 FARAWAVE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0036757158 00191506043193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other