BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 2973510 · Received February 15, 2013

    Report

    Report Number
    1820334-2013-00074
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    COOK INC
    Product Code
    DYB
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE PHYSICIAN: THE DEVICE WAS IN THE PATIENT, WHO HAD NOTABLE CALCIFICATION IN THE GROIN AREA. WHEN ATTEMPTING TO REMOVE THE SHEATH, THE PHYSICIAN ENCOUNTERED DIFFICULTY. AS IT WAS REMOVED, THE DEVICE SHEARED IN TWO. PART OF THE DEVICE WAS OUT OF THE PATIENT AND PART WAS INSIDE THE PATIENT. FROM THE OPPOSITE DIRECTION/SIDE, THE PHYSICIAN ADVANCED AN 8FR SHEATH OVER THE SIRING, STILL INSIDE THE BODY; THEN INFLATED A PTA BALLOON AND PULLED IN THE DEBRIS/BROKEN PART INTO THE LARGER SHEATH. THE PHYSICIAN INDICATED THIS TO BE SUCCESSFUL AND NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69431 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC NA 3865033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention