BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 7681937 · Received July 12, 2018

    Report

    Report Number
    2183870-2018-00374
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 12, 2018
    Report Date
    October 3, 2018
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    UDI-DI
    00643169862982
    PMA / PMN Number
    K111887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE IMAGE WAS RECEIVED FROM CUSTOMER. THE IMAGE SHOWS THE ENTIRE DISTAL SECTION OF THE CATHETER WAS DETACHED. THERE IS EVIDENCE OF THE COIL WINDING UNTANGLED FROM THE COIL/HEATING ELEMENT. PER THE INITIAL REPORT, THE CATHETER HEATING ELEMENT UNRAVELED WITHIN THE PATIENT DURING THE SECOND ABLATION, 2 CM BELOW THE SAPHENOFEMORAL JUNCTION. THE CLOSUREFAST CATHETER WAS NOT RETURNED FOR EVALUATION. WITHOUT THE SAMPLE TO RETURNED FOR EVALUATION A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. POSSIBLE CONTRIBUTING FACTORS SUCH AS: LESION MORPHOLOGY, VESSEL ANATOMY, ANCILLARY DEVICE INTERACTION AND PROCEDURAL TECHNIQUE COULD NOT BE EVALUATED IN THIS INVESTIGATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS USING A CLOSUREFAST DEVICE WITH AN RFG2 GENERATOR TO TREAT A LESION LOCATED IN THE GSV. THE DEVICE WAS NOT REPROCESSED AND THE LUMEN WAS NOT FLUSHED PRIOR TO USE. TUMESCENT INFILTRATION WAS USED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. A GUIDEWIRE WAS NOT USED DURING INSERTION OF THE DEVICE. IT WAS REPORTED THAT THE FIRST ABLATION WAS SUCCESSFUL BUT THAT THE CATHETER HEATING ELEMENT UNRAVELLED WITHIN THE PATIENT DURING THE SECOND ABLATION, 2 CM BELOW THE SAPHENOFEMORAL JUNCTION (SFJ). A 'DEVICE NOT RECOGNISED' MESSAGE THEN ALSO APPEARED ON THE SCREEN. THE PHYSICIAN USED ANOTHER CATHETER WITH THE SAME GENERATOR TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. IT WAS REPORTED THAT SIX SEGMENTS OF THE VEIN WERE SUCCESSFULLY TREATED USING HAND COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525831 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN 173100005 00643169862982

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR