BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 5939080 · Received September 9, 2016

    Report

    Report Number
    2183870-2016-00590
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Date of Event
    July 25, 2016
    Report Date
    August 10, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CLOSUREFAST DEVICE WAS RECEIVED FOR EVALUATION. THE FEP OVER THE COIL REGION WAS OBSERVED TO BE MELTING. THIS AREA OF MELTED FEP INCLUDES A BREACH IN THE FEP SLEEVE RESULTING IN THE COIL BEING EXPOSED. DAMAGE WAS OBSERVED TO THE PET HEAT SHRINK TUBING OVER THE TRANSITION WIRES RESULTING IN A SEPARATION BETWEEN THE CATHETER SHAFT AND THE PROXIMAL END OF THE HEATING ELEMENT. THE CATHETER CABLE CONNECTOR WAS EXAMINED: ALL PINS WERE OBSERVED TO BE STRAIGHT. THE CATHETER PASSED FUNCTIONAL TESTING ON RFG2 AND RFG3 GENERATORS. THE DEVICE WAS RUN FOR TOTAL OF TEN ADDITIONAL CYCLES ON TWO DIFFERENT GENERATORS WITH NO INDICATION OF INCONSISTENT TEMPERATURE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING THE PATIENT USING A CLOSUREFAST CATHETER. THE ACCOUNT REPORTED THAT DURING USE, THE TEMPERATURE WAS NOT STABLE. TEMPERATURE CHANGED FROM 80 TO 90 DEGREES AND ABLATION STOPPED AT THE FIRST ABLATION NEAR THE SAPHENO-FEMORAL JUNCTION (SFJ). THE SITE WAS ABLATED REPEATEDLY. PROCEDURE WAS ABLE TO BE COMPLETED. THE CATHETER WAS FOUND TO BE "BENT" WHEN IT WAS BEING REMOVED FROM THE PATIENT. THE CATHETER WAS REPLACED AND TREATMENT WAS CARRIED OUT ON THE SAME SIDE OF THE SMALL SAPHENOUS VEIN (SSV) WITHOUT INCIDENT. PATIENT IS WAITING FOR ECHOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590319 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN 553198X

    Patients

    Seq Age Sex Outcome Treatment
    1