BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANSEL

    MDR report key: 613135 · Received June 6, 2005

    Report

    Report Number
    613135
    Event Type
    Other
    Date Received
    June 6, 2005
    Date of Event
    April 3, 2005
    Report Date
    June 6, 2005
    Manufacturer
    COOK INC.
    Product Code
    DYB
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A THROMBOLYSIS OF A LEFT LOWER EXTREMITY BYPASS GRAFT. THE PATIENT WAS BROUGHT INTO THE ANGIO SUITE TO REMOVE AN ANSET SHEATH WHICH WAS STUCK IN THE LEFT ILIAC GRAFT. WHILE ATTEMPTING TO REMOVE THE SHEATH IT BROKE. ABOUT 3 INCHES OF THE SHEATH REMAINED IN THE PATIENTS ILIAC ARTERY. WHILE REMOVING THE SHEATH FROM THE RIGHT GROIN, THE WIRE WHICH WAS CAUGHT ON THE SHEATH BEGAN TO UNRAVEL. THE PATIENT REQUIRED AN ADDITIONAL GROIN PUNCTURE TO THE LEFT SIDE TO SNARE THE BROKEN CATHETER OUT. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED. THE PATIENT THEN HAD BOTH GROINS (PRESSURE) MANUALLY HELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANSEL SHEATH DYB COOK INC. * CZ7211

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR