BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER 8MM NAVISTAR ABLATION CATHETER

    MDR report key: 23706047 · Received December 3, 2025

    Report

    Report Number
    MW5179816
    Event Type
    Injury
    Date Received
    December 3, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ABLATION FOR ATRIAL FIBRILLATION, THE PATIENT WAS NOTED TO HAVE A PARTIAL THICKNESS BURN APPEARING AS IF IT WAS INTO THE DERMIS, BUT NOT SUBCUTANEOUS ON THE LEFT FLANK OF THE LOWER BACK FROM WHERE THE GROUNDING PAD WAS FOR THE PROCEDURE. THE BURN WAS TREATED WITH HYDROGEL, WOUND GEL DRESSING, AND GAUZE DRESSING WITH FOAM BORDER. THE PATIENT WAS ADMITTED OVERNIGHT FOLLOWING THE PROCEDURE FOR WOUND CONSULTATION AND WOUND CARE TO BE ADMINISTERED. THE PATIENT WAS DISCHARGED THE FOLLOWING MORNING WITH FOLLOW-UP ORDERS TO RECEIVE OUTPATIENT WOUND CARE TREATMENT (WEEKLY). THERE WAS NO DIFFICULTY DURING PROCEDURE, THE SURGICAL FIELD WAS DRY, THE GENERATOR SETTINGS WAS 50W 60*C LIMITS, AND NO ALARMS WERE ACTIVATED, THE BURN WAS NOTICED AFTER PROCEDURE DUE TO PATIENT INTUBATION AND UNABLE TO RESPOND WHEN BURN TOOK PLACE. THE GENERATOR AND CATHETER USED WERE NON-MEDTRONIC DEVICES. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2808049 BIOSENSE WEBSTER 8MM NAVISTAR ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. BIOSENSE WEBSTER 8MM NAVISTAR ABLATION CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female