BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER 20, 2-6-2, 135

    MDR report key: 521336 · Received January 29, 2004

    Report

    Report Number
    2951009-2004-00014
    Event Type
    Malfunction
    Date Received
    January 29, 2004
    Date of Event
    November 27, 2003
    Report Date
    January 28, 2004
    Manufacturer
    CARDIMA, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "DURING THE CS MAPPING PROCEDURE, A TIP OF A PATHFINDER 20 REMAINED IN THE CS WHILE THE DOCTOR WAS TRYING TO INSERT THE CATHETER TO THE DEPTH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER 20, 2-6-2, 135 PATHFINDER DRF CARDIMA, INC. 01-201001 M1955

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN