BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 11575485 · Received March 26, 2021

    Report

    Report Number
    2183870-2021-00114
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 12, 2021
    Report Date
    March 26, 2021
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    UDI-DI
    00643169862982
    PMA / PMN Number
    K111887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO USE A CLOSUREFAST ABLATION DEVICE ALONG WITH A RADIOFREQUENCY GENERATOR DURING PROCEDURE TO TREAT 7 SEGMENTS IN THE SHORT SAPHENOUS VEIN (SSV). COMPRESSION WAS USED. THE LUMEN WAS FLUSHED PRIOR TO USE. IFU WAS FOLLOWED. PROPER TEMPERATURE WAS REACHED. THE PRODUCT WAS NOT FOUND DURING FIELD CYCLE COUNTS. 3 FILED CYCLE COUNT WERE PERFORMED BETWEEN (B)(6) 2020 AND (B)(6) 2021. THE THEATRE STOCK CONTROLLERS WERE ADVISED THAT THE PRODUCT WAS NOT FOUND AND SHORT DATED AND THEREAFTER EXPIRED. THE PRODUCT WAS USED ON A PATIENT ON (B)(6) 2021 BUT THE DEVICE HAD EXPIRED (B)(6) 2021. ON USAGE OF THE ITEM, THE STOCK CONTROLLER PICKED UP THAT THE MISSING ITEM WAS USED. THEY ARE UNSURE HOW THE ITEM RESURFACED. THERE WERE NO COMPLICATIONS DURING AND AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473867 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN CF7-7-100 UNK 00643169862982

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR