BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 476651 · Received July 26, 2003

    Report

    Report Number
    MW4003563
    Event Type
    Malfunction
    Date Received
    July 26, 2003
    Date of Event
    February 28, 2002
    Report Date
    June 26, 2003
    Manufacturer
    CARDIMA, INC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR A PROCEDURE TO CORRECT AN IRREGULAR HEARTBEAT BUT DURING THE PROCEDURE THE DISTAL END OF THE CATHETER BROKE OFF AND REMAINS LODGED IN THE LOWER LOBE OF RIGHT LUNG. THE CARDIOLOGIST HAS OPINED THAT THE DANGERS OF THE CATHETER BREAKING FREE AND CAUSING DAMAGE ARE "REMOTE". PRODUCT HAS NOT PERFORMED AS IT WAS UNDOUBTEDLY DESIGNED AND REMAINS LODGED IN PT'S CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER DQO CARDIMA, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *