BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KELLER-TIMMERMANS STRAIGHT GUIDING SHEATH

    MDR report key: 1368928 · Received April 24, 2009

    Report

    Report Number
    1820334-2009-00198
    Event Type
    Injury
    Date Received
    April 24, 2009
    Date of Event
    March 17, 2009
    Report Date
    March 27, 2009
    Manufacturer
    COOK INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IN 2009, THE PHYSICIAN PERFORMED ENDOVASCULAR REPAIR TO TREAT AN ANEURYSM OF THE THORACIC DESCENDING AORTA. TWO OTHER MANUFACTURER'S DEVICES WERE USED AND A COOK KTI SHEATH. FIRST DEVICE INSERTED DISTALLY AND WAS FLOATING IN THE ANEURYSM SAC. THE PHYSICIAN THEN INSERTED A COOK KTI SHEATH INTO THE DEVICE AND ATTEMPTED TO ADVANCE IT PROXIMALLY TO ENTER THE SECOND DEVICE. HOWEVER, AS THE PROXIMAL END OF THE DEVICE WAS TOO CLOSE TO THE INNER WALL OF THE ANEURYSM, THE KTI SHEATH WAS BLOCKED BY THE INNER WALL OF THE ANEURYSM AND COULD NOT READILY PASS THROUGH THE DEVICE. IT WAS NOTED THAT THE KTI SHEATH MIGHT HAVE SCRAPED OFF EMBOLISM DURING THIS ATTEMPT. AFTER SURGERY, PATIENT'S RIGHT LEG WAS PARALYZED. THE PULSES WERE NORMAL IN BOTH LEGS AND THE PHYSICIAN PERFORMED A SPINAL DRAINAGE. A WEEK LATER, THE PATIENT'S LEFT LEG WAS ALSO PARALYZED. AT THIS TIME, THE PATIENT IS TO START REHABILITATION AND IS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KELLER-TIMMERMANS STRAIGHT GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R