BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 300114 · Received October 10, 2000

    Report

    Report Number
    MW1020139
    Event Type
    Injury
    Date Received
    October 10, 2000
    Date of Event
    September 6, 2000
    Report Date
    October 10, 2000
    Manufacturer
    BIOSENSE WEBSTER INC./DIV JOHNSON & JOHNSON CORP.
    Product Code
    DRF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CATHETER THERMAL ABLATION FOR RIGHT VENTRICULAR OUTFLOW ACCESSORY PATHWAY. IMMEDIATELY FOLLOWING PROCEDURE, PT EXPERIENCED CARDIAC TAMPONADE, HYPOTENSION. PERICARDIUM WAS EVACUATED BUT THE FLUID COLLECTION CONTINUED. PT THEN UNDERWENT MEDIASTINOTOMY AND REPAIR OF MYOCARDIAL PERFORATION IN THE RIGHT VENTRICULAR APEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER 6F COURNAND QUAD DIAGNOSTIC CATHETER 10MM SPACING DRF BIOSENSE WEBSTER INC./DIV JOHNSON & JOHNSON CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R D CURVE THERMO ABLATION CATHETER