BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 428945 · Received November 19, 2002

    Report

    Report Number
    MW1026792
    Event Type
    Injury
    Date Received
    November 19, 2002
    Date of Event
    September 17, 2002
    Report Date
    November 9, 2002
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DQK
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR AN OUTPATIENT EP STUDY & CARDIAC ABLATION FOR 20 YEAR PLUS HISTORY OF PSVT TREATED BD INCREASING DOSES OF VERAPAMIL. PSVT EPISODES HAD INCREASED IN FREQUENCY & DURATION OVER THE YEARS, BUT THE HIGHER DOSES OF VERAPAMIL WERE CAUSING PROBLEMS. PT WAS THE 2ND PATIENT THAT THIS NEWLY INSTALLED EQUIPMENT WAS USED ON. PT HAD THE ABLATION & THE 2ND SHOT OF LASER HIT THEIR AV NODE FOR 5.2 SECONDS SENDING PT INTO COMPLETE HEART BLOCK. THE MD SAID HE "DID NOT KNOW HOW THIS HAPPENED" AS THE "CATHETER TIP WAS NO WHERE NEAR THE AV NODE". PT NOW HAS A PERMANENT PACEMAKER & HAD BEEN ADMITTED TO THE TELEMETRY UNIT FOR A 4 DAY ADMISSION. THERE WAS AT LEAST ONE COMPANY TECHNICIAN IN THE PROCEDURE ROOM TELLING THE NURSES WHAT TO DO. PT'S PROCEDURE WAS DELAYED FROM "PROBLEMS" W/THE MACHINE" FROM THE 1ST PATIENT, PT DOES NOT FEEL THE PEOPLE, INCLUDING THE MD, HAD ENOUGH TRAINING USING THIS EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CARTO EP SYSTEM DQK BIOSENSE WEBSTER, INC. * *
    2 BIOSENSE WEBSTER NAVI-STAR LASER CATHETER LPB BIOSENSE WEBSTER, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R