BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 5980025 · Received September 27, 2016

    Report

    Report Number
    2183870-2016-00607
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    July 12, 2016
    Report Date
    August 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CLOSUREFAST CATHETER WAS RECEIVED FOR EVALUATION. SEVERAL KINKS WERE NOTED IN THE CATHETER. THE KINKS ARE LOCATED APPROXIMATELY 38.5MM, 48.0MM, 56.1MM AND 70.9MM PROXIMAL OF THE DISTAL TIP OF THE CATHETER. VISUAL INSPECTION OF THE CATHETER REVEALED A TORN CATHETER SHAFT LUMEN. THE TORN SHAFT AREA LOCATED APPROXIMATELY IN THE REGION OF 12MM TO 12.4MM. THE TORN SHAFT AREA WAS OBSERVED TO HAVE THERMOCOUPLE WIRES BEING EXPOSED AND A GREEN THERMOCOUPLE WIRE WAS OBSERVED TO BE TORN IN HALF.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE A CLOSUREFAST CATHETER DURING PROCEDURE FOR TREATMENT OF THE GREAT SAPHENOUS VEIN. THE LUMEN WAS FLUSHED PRIOR TO USE. AN RFG3 WAS USED WITH THE CATHETER. THE IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. THE PROPER TEMPERATURE WAS REACHED. LOCAL ANESTHESIA AND TUMESCENT INFILTRATION WERE UTILIZED WITH TRANSDUCER COMPRESSION. IT IS REPORTED THAT THE CATHETER KINKED DURING THE PROCEDURE. THE KINK WAS LOCATED DISTAL. THE CATHETER BROKE JUST PROXIMAL TO HEATING COIL WHEN IN VEIN. IT IS REPORTED THAT HALFWAY THROUGH HEATING AND PULL BACKS, THE CATHETER BROKE IN HALF AND WOULD NOT PULL BACK ANY FURTHER. DEVICE BROKE IN HALF BUT DID NOT COME DETACHED AT THE COIL ITSELF. IT IS REPORTED THAT IT WAS DIFFICULT TO REMOVE BUT THE SALE REPRESENTATIVE INSTRUCTED ON THE PHONE TO PULL THE SHEATH AND CATHETER OUT AT THE SAME TIME, AND IT CAME OUT. IT IS REPORTED THAT A NEW CATHETER HAD TO BE OPENED TO COMPLETE THE PROCEDURE. ADDITIONAL TREATMENT WAS NOT REQUIRED. IT IS REPORTED THAT THE VEIN CLOSED AND SIX SEGMENTS WERE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633186 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN CF7-7-100

    Patients

    Seq Age Sex Outcome Treatment
    1