BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MICROPUNCTURE INTRODUCER SET

    MDR report key: 1933968 · Received December 16, 2010

    Report

    Report Number
    MW5018641
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 16, 2010
    Manufacturer
    COOK MEDICAL INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT OF IVC FILTER, THE RIGHT GROIN WAS ACCESSED WITH MICROPUNCTURE. WHILE ATTEMPTING TO PLACE GUIDEWIRE INTO FEMORAL VEIN, THE GUIDEWIRE BECAME TANGLED AROUND ITSELF. FEMORAL VEIN WAS THEN ACCESSED ON OPPOSITE SIDE AND GUIDEWIRE SNARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK MICROPUNCTURE INTRODUCER SET NONE DYB COOK MEDICAL INC #MPIS-501-SST 2576768

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability