BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHECK-FLO SHEATH INTRODUCER SET

    MDR report key: 1073671 · Received July 9, 2008

    Report

    Report Number
    1820334-2008-00343
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 10, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    WHILE TESTING FOR A HEART DEFECT IN A CHILD, THE DEVICE BROKE IN THE MIDDLE OF THE FLEXOR MATERIAL AND FRAYED. A 55 CM 5 FRENCH SHEATH WAS USED TO DELIVER A VASCULAR PLUG IN A MALE PT. THE VASCULAR PLUG SUGGESTS USING A 6 FRENCH GUIDING CATHETER OF A 5 FRENCH FOR DELIVERY. THE DELIVERY WENT SMOOTHLY. HOWEVER, WHEN THE SHEATH WAS PULLED OUT OF THE AORTA, THE VESSEL SPASMED AND RESISTANCE WAS FELT. THE DILATOR AND WIRE WERE OUT BACK IN AND SHEATH PULLED BACK. RESISTANCE FELT AND THEN A "POP" SOUND WAS HEARD. THE COATING ON THE SHEATH HAD SNAPPED AND THE BRAIDING BEGAN TO UNRAVEL ( SNAPPED INTO TWO PIECES). THE REMAINS OF THE SHEATH WERE PULLED OUT THROUGH A 6 FRENCH SHEATH PLACED IN THE OPPOSITE SIDE. PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHECK-FLO SHEATH INTRODUCER SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2078249

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Required Intervention