BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM-CELECT-PEM

    MDR report key: 3955765 · Received July 21, 2014

    Report

    Report Number
    MW5037367
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 18, 2014
    Manufacturer
    COOK
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH DVT POOR CANDIDATE FOR LONG-TERM ANTICOAGULATION THUS AN IVC FILTER PLACEMENT WAS INDICATED. THE IVC FILTER PERFORATED AND SHEATH WITHIN THE RIGHT COMMON FEMORAL VEIN. THE FILTER HAD TO BE DEPLOYED WITHIN THE RIGHT COMMON ILIAC VEIN. HE DID HAVE A SECOND FILTER PLACED IN THE NORMAL INFRARENAL POSITION, PROTECTING HIM FROM DVT. THE FOLLOWING DAY, THE PT WAS BROUGHT BACK TO SURGERY TO ATTEMPT TO REMOVE THE FILTER. THE HOOK APPEARED TO BE EMBEDDED IN THE WALL OF THE VEIN SO IT COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426396 FEM-CELECT-PEM FEM-CELECT-PEM DTK COOK E3210846

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization| R