BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLOSUREFAST CATHETER, 7F, 100CM

    MDR report key: 2465140 · Received February 17, 2012

    Report

    Report Number
    2953189-2012-00046
    Event Type
    Death
    Date Received
    February 17, 2012
    Date of Event
    February 5, 2012
    Report Date
    February 6, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT PATIENT EXPIRED ON (B)(6) 2012. THE CUSTOMER STATES THAT A FEMALE PATIENT APPROXIMATELY (B)(6) YEARS OLD WAS TREATED WITH A RFA ABLATION PROCEDURE ON (B)(6) 2012. THE PATIENT WAS OBESE, DIABETIC, AND A HEAVY SMOKER. THE PATIENT WAS PRESENTED WITH AN ACTIVE CEAP 5 ULCER. THE RFA ABLATION PROCEDURE WENT VERY SMOOTHLY WITHOUT COMPLICATIONS. THE RVT NOTED THAT DISTAL TIP OF THE CLOSUREFAST CATHETER WAS OVER 2 CM DISTAL TO THE SFJ AND POSTOPERATIVELY THE JUNCTION WAS EXAMINED VIA ULTRASOUND AND ANY SIGN OF DVT WAS RULED OUT. THE PATIENT RETURNED TO WORK. THE PATIENT PASSED AWAY OVER THE WEEKEND ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSUREFAST CATHETER, 7F, 100CM CLOSUREFAST CATHETER, 7F, 100CM GEI COVIDIEN CF7-7-100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death