BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRMAP CATHETER, 70MM, EU

    MDR report key: 3810257 · Received March 19, 2014

    Report

    Report Number
    3009385307-2014-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MEDFACT ENGINEERING GMBH
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE MAPPING PROCEDURE THE CATHETER WAS HEAVILY TWISTED WHILE FULLY DEPLOYED IN THE LEFT ATRIUM, AN ACTION THAT IS CAUTIONED AGAINST IN THE PRODUCT LABELING. SPLINE A SIGNALS FROM FIRMAP 70MM ELECTRODES 1-6 COULD NOT BE READ AND LATER SIGNALS FROM ELECTRODES 7-8 COULD NOT BE READ. FOLLOWING THE MAPPING, UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT SPLINE C OF THE FIRMAP 70MM CATHETER HAD BECOME DISCONNECTED FROM THE PROXIMAL SHAFT DURING THE REMOVAL/EXTRACTION PROCESS. THERE WAS NO PT INJURY REPORTED AND THE DIAGNOSTIC PROCESS WITH THE FIRMAP CATHETER WAS SUCCESSFUL, ALLOWING FOR SUBSEQUENT TREATMENT OF THE PT. REF# MFR 3008497357-2014-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163469 FIRMAP CATHETER, 70MM, EU MAPPING CATHETER MTD MEDFACT ENGINEERING GMBH EU-AR064070 EUAR064070251013

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR