BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHUTTLE SELECT TUOHY BORST SIDE-ARM INTRODUCER SET

    MDR report key: 956519 · Received November 27, 2007

    Report

    Report Number
    MW5004565
    Event Type
    Other
    Date Received
    November 27, 2007
    Date of Event
    November 15, 2007
    Report Date
    November 27, 2007
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    WHEN MD WAS DOING AN INJECTION TO THE CAROTID ARTERY THE TUOHY-BORST CONNECTED TO THE SUTTLE SHEATH BROKE. THE STENT HAD BEEN DEPLOYED IN THE INTERNAL CAROTID ARTERY, BUT AIR BUBBLES WERE ADVANCED IN THE EXTERNAL CAROTID ARTERY. PATIENT EXPERIENCED MINIMAL VISION BLURRINESS, WHICH RESOLVED IN MINUTES, AND NUMBNESS IN THE FACE, WHICH ALSO RESOLVED WITHIN MINUTES. DIAGNOSIS OR REASON FOR USE: CAROTID STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUTTLE SELECT TUOHY BORST SIDE-ARM INTRODUCER SET NONE DYB COOK INCORPORATED KSAW-6.0-38-90-RB-S 1866253

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other