BEUDAMED
    FDA Adverse Event Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 3104766 · Received May 6, 2013

    Report

    Report Number
    MW5030095
    Date Received
    May 6, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER ATRIAL FIB ABLATION TRANSSEPTAL SHEATHS WERE PULLED BACK INTO THE RA. PT WAS CARDIOVERTED AND DURING RAP, HE WENT INTO TYPICAL ATRIAL FLUTTER, RFA OF CTI WAS INITIATED. DURING ONE LESION, A POP WAS HEARD AND RFA WAS IMMEDIATELY TERMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197305 BIOSENSE WEBSTER THERMACOOL OAD BIOSENSE WEBSTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization