BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOGA-STAR CARDIOLOGY

    MDR report key: 3801865 · Received May 8, 2014

    Report

    Report Number
    3801865
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER NEVER ENTERED PATIENT. AFTER REMOVING IT FROM THE STERILE PACKAGE, THE DEVICE FAILED TO BE RECOGNIZED BY ABLATION ROOM'S "MAPPING SYSTEM"; THEREFORE, COULD NOT BE USED ON THE PATIENT. MAPPING SYSTEM FACILITATES LOCATION OF ELECTRICAL POTENTIALS FOR MAPPING AND POTENTIAL ABLATION. A NEW 2MM NOGA STAR WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279516 NOGA-STAR CARDIOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC. * 16031710M

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR