BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRMAP CATHETER, 70MM, EU

    MDR report key: 3810255 · Received March 19, 2014

    Report

    Report Number
    3008497357-2014-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Manufacturer
    MEDFACT ENGINEERING GMBH
    Product Code
    MTD
    PMA / PMN Number
    K130827
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), A (B)(4) CLINICAL MANAGER, WAS ON-SITE AT THE HOSPITAL AT THE TIME OF THE INCIDENT. HE REPORTED THE INCIDENT TO (B)(4) FOR DR (B)(4). (B)(4) WORKED WITH MEDFACT ENGINEERING TO OBTAIN AND INVESTIGATE THE DEVICE MALFUNCTION. DURING A PHONE INTERVIEW WITH (B)(4) IMMEDIATELY FOLLOWING THE REPORT ON (B)(6) 2014, (B)(4) REPORTED THAT THE CATHETER WAS DEPLOYED SEVERAL TIMES DURING THE PROCEDURE, WHICH IS STANDARD; HOWEVER, DURING THIS PROCEDURE, THE PHYSICIAN TWISTED THE CATHETER 2 OR 3 TIMES WHILE IT WAS DEPLOYED IN AN ATTEMPT TO RE-POSITION IT. THE CATHETER WAS PULLED BACK INTO THE INTRODUCER SEVERAL TIMES SUCCESSFULLY. ON THE LAST RETURN TO THE INTRODUCER, THE SPLINE WAS STICKING OUT OF THE INTRODUCER.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163393 FIRMAP CATHETER, 70MM, EU MAPPING CATHETER MTD MEDFACT ENGINEERING GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1