BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPERA FIRMAP

    MDR report key: 5395936 · Received January 28, 2016

    Report

    Report Number
    5395936
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Date of Event
    April 2, 2015
    Report Date
    January 18, 2016
    Manufacturer
    MEDFACT ENGINEERING GMBH
    Product Code
    MTD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BASKET CATHETER PLACED WITHIN SHEATH AND INTRODUCED INTO PATIENT, BASKET DEPLOYED AND SPLINE DETACHED FROM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54510 TOPERA FIRMAP CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY MTD MEDFACT ENGINEERING GMBH 40308231

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR