BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE

    MDR report key: 24686147 · Received March 25, 2026

    Report

    Report Number
    2124215-2026-16239
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE FARAWAVE PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION AND SUPRAVENTRICULAR TACHYCARDIA SVT A FARAWAVE 2.0 NAV WAS SELECTED FOR USE. DURING ABLATION OF A LEFT COMMON PULMONARY VEIN, THE INITIAL ISSUE WAS A STUCK GUIDEWIRE, IT WAS UNABLE TO ADVANCE OR RETRACT. WHEN RETRACTED, THE CATHETER TIP WOULD FOLLOW AND EXPAND THE BASKET AND WHEN ADVANCED WOULD UNDEPLOY. WITH SOME FORCE, THE CATHETER AND WIRE WERE FREED UP AND REMOVED FROM THE BODY. THE DEVICE WAS INSPECTED AND A BIT OF TISSUE WAS OBSERVED AT THE WIRE/LUMEN JUNCTION. THE CATHETER WAS PREPPED AND REINSERTED AND AFTER FINISHING THE LEFT VEIN SET, IT WAS NOTICED THAT THE WIRE WAS DIFFICULT TO ADVANCE/RETRACT AGAIN. CONCERNED WITH TISSUE EMBOLIZATION, THE CATHETER WAS AGAIN REMOVED. AFTER INSPECTION, IT APPEARED THERE WAS A ROUGH EDGE AT THE CATHETER TIP, UNKNOWN IF IT IS TISSUE, CATHETER, OR WIRE REMNANTS. THE GUIDEWIRE WAS UNABEL TO BE REMOVED AND IT WAS PAST THE TIP OF THE CATHETER WHEN THE CATHETER WAS REMOVED. NO OTHER CATHETER MALFUNCTIONS WERE PRESENT. SEE ATTACHED PHOTOS. A NEW DEVICE WAS THEN OPENED AND USED TO FINISH THE PROCEDURE. THERE WERE NO HEMODYNAMIC CHANGES AND THE FLUORO AND ECHO (ICE) IMAGES APPEARED TO BE WITHOUT PERICARDIAL EFFUSION. NO PATIENT COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752716 FARAWAVE No Match QZI BOSTON SCIENTIFIC CORPORATION 0037851107 00191506043193

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female