BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRMAP CATHETER, 50MM, US

    MDR report key: 4349949 · Received November 25, 2014

    Report

    Report Number
    3009385307-2014-00005
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    October 9, 2014
    Report Date
    November 24, 2014
    Manufacturer
    MEDFACT ENGINEERING GMBH
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE PROCEDURE, ANOTHER DEVICE BECAME ENTANGLED WITHIN THE 50MM FIRMAP BASKET CATHETER. IN THE LAB STAFF MEMBER'S ATTEMPT TO RETRACT THE FIRMAP, RESISTANCE TO PULLING THE FIRMAP BACK WAS EXPERIENCED BUT THE MEMBER CONTINUED TO PULL THE CATHETER BACK WITH MORE FORCE. THE CATHETER BASKET WAS COLLAPSED INTO, AND PULLED MOSTLY BACK THROUGH, THE DISTAL END OF THE SHEATH WHEN THE BASKET SEPARATED FROM THE CATHETER SHAFT. WITH THE BASKET PROTRUDING APPROXIMATELY 1.5 CM FROM THE TOP OF THE SHEATH, THE ENTIRE SHEATH WAS REMOVED FROM THE PATIENT BY THE PHYSICIAN. NO PATIENT INJURY HAS BEEN REPORTED AND THE DIAGNOSTIC MAPPING PROCESS HAD ALREADY BEEN SUCCESSFULLY COMPLETED WITH THIS CATHETER. EXCESSIVE FORCE IS CAUTIONED AGAINST IN THE PRODUCT LABELING AND IN PHYSICIAN TRAINING MATERIALS. LABELING AND TRAINING ALSO CAUTION THAT OTHER CATHETERS USED CONCURRENTLY WITH FIRMAP NEED TO BE REMOVED BEFORE REPOSITIONING OR REMOVING THE FIRMAP. REFERENCE MFR # 3008497357-2014-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764849 FIRMAP CATHETER, 50MM, US MAPPING CATHETER MTD MEDFACT ENGINEERING GMBH US-ARO64050 50US280114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other