BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR THERMOCOOL CATHETER

    MDR report key: 1232806 · Received November 9, 2008

    Report

    Report Number
    1232806
    Event Type
    Malfunction
    Date Received
    November 9, 2008
    Date of Event
    September 10, 2008
    Report Date
    November 9, 2008
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BARELY ANY FLUID COMING OUT OF THE TIP OF THE THERMOCOOL. LITTLE FLUID COMING OUT EVEN WHILE PUMP RAN AT 60ML/MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMOCOOL CATHETER CATHETER, ABLATION, EP DRF BIOSENSE WEBSTER NA 13413208

    Patients

    Seq Age Sex Outcome Treatment
    1 *