BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRMAP CATHETER, 60MM, US

    MDR report key: 4147732 · Received October 2, 2014

    Report

    Report Number
    3009385307-2014-00003
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDFACT ENGINEERING GMBH
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF THE 60MM FIRMAP CATHETER, IT WAS NOTED THAT ONE OF THE CATHETER SPLINES WAS BROKEN AT THE DISTAL END. NO PT INJURY HAS BEEN REPORTED AND THE DIAGNOSTIC MAPPING PROCESS WAS SUCCESSFULLY COMPLETED WITH THIS CATHETER. THE TOPERA EMPLOYEE ON-SITE DURING THE CASE NOTED THAT THE ABLATION CATHETER IN USE WITH THE FIRMAP CATHETER BECAME ENTANGLED IN THE FIRMAP SEVERAL TIMES DURING THE PROCEDURE. THIS ENTANGLEMENT WITH THE ABLATION CATHETER MAY HAVE CREATED THE BREAK DURING ATTEMPTS TO RETURN THE FIRMAP TO THE SHEATH IF EXCESSIVE FORCE WAS USED. EXCESSIVE FORCE IS CAUTIONED AGAINST IN THE PRODUCT LABELING AND IN PHYSICIAN TRAINING MATERIALS. TOPERA HAS REQUESTED THE RETURN OF THE CATHETER FOLLOWING THE HOSPITAL'S EVALUATION, BUT HAS NOT RECEIVED THE DEVICE. MFR REF# 3008497357-2014-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614573 FIRMAP CATHETER, 60MM, US MAPPING CATHETER MTD MEDFACT ENGINEERING GMBH US-ARO64060 60US150414-1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR