BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARASTAR

    MDR report key: 22214586 · Received June 16, 2025

    Report

    Report Number
    2124215-2025-39519
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS NOT OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION (PFA) PROCEDURE THE FARASTAR MSM NAM WAS SELECTED FOR USE, DURING FARAVIEW CASE. DURING THE CASE, THE MAPPER OBSERVED ERROR 301 WHILE ATTEMPTING TO DELIVER PFA INITIALLY. MAPPER CONFIRMED ALL CONNECTIONS WHICH DID NOT RESOLVE THE ISSUE. MAPPER THEN EXCHANGED CATHETER WHICH DID NOT RESOLVE THE ISSUE. THE MAPPER REBOOTED THE ENTIRE SYSTEM. MAPPER AGAIN CONFIRMED THAT CONSOLE TO STIM CABLE WAS CONNECTED AND SECURE, THE RSM TO MSM AUX CABLE WAS CONNECTED AND SECURE, AND BOTH RSM AND MSM WERE POWERED ON AND IN A READY STATE (NOT TEST MODE). MAPPER THEN DELIVERED THERAPY SUCCESSFULLY. MAPPER TRIED TO DELIVER THERAPY A SECOND TIME AND AGAIN GOT 301. PHYSICIAN ASSURED GOOD CATHETER POSITION AND AGAIN ATTEMPTED TO DELIVERY THERAPY WHICH AGAIN PRODUCED A 301 ERROR. THE CATHETER WAS THEN CONNECTED DIRECTLY TO THE FARASTAR CONSOLE (BYPASSING THE MSM). THE TEAM WAS ABLE TO DELIVERY THERAPY SUCCESSFULLY THREE TIMES IN A ROW. NO PATIENT COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THE FARASTAR DEVICE IS EXPECTED TO BE RETURNED. IT WAS FURTHER REPORTED THAT THE CASE WAS CANCELLED MID-PROCEDURE BECAUSE THE OPAL MAPPING SYSTEM COULDN'T BE USED; ONLY ICE AND FLUOROSCOPY WERE AVAILABLE. ALTHOUGH THE CATHETER CONNECTED TO THE CONSOLE, THE PHYSICIAN DECIDED NOT TO CONTINUE WITHOUT MAPPING INTEGRATION. AFTER 45 MINUTES OF TROUBLESHOOTING, IT WAS DETERMINED THAT THE MSM OR AUX CABLE WAS FAULTY. FSE TESTING LATER CONFIRMED THE MSM WAVEFORM WAS OUT OF TOLERANCE, CAUSING THE FARASTAR TO THROW A 301 ERROR. THE FIRST CATHETER REPLACEMENT WAS DUE TO PERSISTENT SPLINE INVERSION, AND THE SECOND WAS IN RESPONSE TO THE 301 ERROR, ASSUMING IT WAS CATHETER-RELATED. THE GEN 2 CABLE WAS REPLACED ONCE TO TROUBLESHOOT THE PERSISTENT CONSOLE ERROR. HOWEVER, NEITHER CATHETER NOR CABLE REPLACEMENT RESOLVED THE ISSUE. THE MSM WAS CONFIRMED DEFECTIVE AND WAS THE TRUE CAUSE. ONLY TWO CATHETERS WERE SWAPPED. THE SHEATH WAS NOT DEFECTIVE, BUT THE CASE WAS CANCELED BECAUSE OPAL WAS NON-FUNCTIONAL AND ESSENTIAL FOR NAVIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593407 FARASTAR CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM GENERATOR QZI BOSTON SCIENTIFIC CORPORATION M004PF61M601 0107931729 00191506043841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown