BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 FR SHEATH

    MDR report key: 3181420 · Received June 14, 2013

    Report

    Report Number
    2183787-2013-00041
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSERTION WAS TIGHT UNDER THE CLAVICLE. BOTH SHEATHS KINKED, SPLIT AND THEN SPLIT/PERFORATED THE CEPHALIC VEIN, UNABLE TO ADVANCE SHEATH BECAUSE VEIN WAS DAMAGED. MOVED ONTO 2X SUBCLAVIAN PUNCTURE. THERE WERE NO COMPLICATIONS BUT SUBCLAVIAN PUNCTURE COULD HAVE BEEN AVOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272050 8 FR SHEATH INTRODUCER DYB MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other