BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARASTAR

    MDR report key: 24136336 · Received January 21, 2026

    Report

    Report Number
    2124215-2026-03908
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 9, 2026
    Report Date
    April 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES, HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE, TO TREAT A PERSISTENT ATRIAL FIBRILLATION A FARASTAR PFA GENERATOR ONLY WAS SELECTED FOR USE. WHEN THE CATHETER WAS CONNECTED TO THE MSM, A MAGNETIC ISSUE WAS DETECTED, PROMPTING REPLACEMENT OF THE CONNECTION CABLE, WHICH RESOLVED THE INITIAL PROBLEM. THE CATHETER WAS POSITIONED IN BASKET SHAPE IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV), BUT ERROR 301: PRE-PULSE FAILURE APPEARED. THE CATHETER WAS ROTATED AND THE BASKET RESIZED, BUT THE ERROR PERSISTED. THE PHYSICIAN THEN CHANGED THE CATHETER TO FLOWER SHAPE, AND THE SAME ERROR REOCCURRED. THE SIS, MSM, RSM, AND GENERATOR WERE REBOOTED. HOWEVER, WHEN ATTEMPTING DELIVERY IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), BOTH IN BASKET AND FLOWER POSITION, THE 301 ERROR REAPPEARED. THE CATHETER WAS REPLACED, BUT THE ERROR OCCURRED AGAIN ONCE POSITIONED IN THE LSPV. ADDITIONAL ATTEMPTS IN FLOWER POSITION IN THE RIGHT UPPER ATRIUM ALSO RESULTED IN THE 301 ERROR. THE GENERATOR WAS REBOOTED, THE GENERATOR CABLE WAS REPLACED, AND THE FULL SYSTEM WAS RESTARTED. ALTHOUGH THERE WERE NO ISSUES DURING BOOT-UP, THE 301 ERROR CONTINUED DURING DELIVERY ATTEMPTS. THE CATHETER CABLE WAS REPLACED AGAIN WITHOUT IMPROVEMENT. A BYPASS OF THE PRE-PULSE SETTING WAS ATTEMPTED, BUT THE GENERATOR NO LONGER RECOGNIZED THE CATHETER. MULTIPLE REBOOT CYCLES WERE PERFORMED, INCLUDING DISCONNECTING THE CATHETER AND GENERATOR CABLE, THEN RECONNECTING THEM. AFTER SHUTTING DOWN THE MSM AND CYCLING THE TEST SWITCH POST-BOOT, THE CATHETER WAS FINALLY RECOGNIZED. THERAPY WAS THEN ATTEMPTED AND DELIVERED WITHOUT 301 ERRORS; HOWEVER, THERE WAS NO OBSERVABLE EFFECT ON THE EGM SIGNALS. THE FARASTAR WINDOW IN OPAL DISPLAYED EITHER "INCOMPLETE" OR REMAINED BLANK, AND LESIONS WERE NOT LOGGED. THE OPAL SYSTEM WAS REBOOTED, AND A COMPLETE SET OF APPLICATIONS WAS PERFORMED IN THE RSPV (TWO BASKET AND TWO FLOWER), CONFIRMING NO CHANGES IN EGM SIGNALS. THE FARASTAR INDICATOR CONTINUED TO SHOW NO OUTPUT OR "INCOMPLETE." AFTER TROUBLESHOOTING, IT WAS DETERMINED THAT THE GENERATOR AND POTENTIALLY THE WAVEFORM WAS MALFUNCTIONING. FINALLY, THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE. IT'S UNKNOWN IF THE GENERATOR WILL RETURN FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198484 FARASTAR CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR QZI BOSTON SCIENTIFIC CORPORATION 0105459922

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male