BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM 18

    MDR report key: 169293 · Received May 11, 1998

    Report

    Report Number
    2951420-1998-00007
    Event Type
    Other
    Date Received
    May 11, 1998
    Report Date
    April 3, 1998
    Manufacturer
    MEDTRONIC MIS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE JETSTREAM CATHETER WAS IN THE ANTERIOR CAROTID ARTERY (ACA), AND THE JETSTREAM RUPTURED UPON GIVING A CONTRAST MEDIA INJECTION. FIRST, THE PHYSICIAN NOTICED THAT NOTHING CAME OUT OF THE CATHETER, THEN NOTICED THAT EVERYTHING CAME OUT OF THE RUPTURED PART. THE PROXIMAL HUB OF THE JETSTREAM 18 HAD BEEN REMOVED AND REPLACED WITH A TOUEY-BORST CONNECTOR, AND A 1 CC SYRINGE HAD BEEN ATTACHED. BY USING A 1 CC SYRINGE CAN GENERATE MORE PRESSURE WHICH COULD RUPTURE THE SHAFT. CLEARLY, THE USER MODIFIED THE PRODUCT, PRODUCING AN ADULTERATED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM 18 JETSTREAM MICRO CATHETER DQO MEDTRONIC MIS MC18401 C102596-MC23626

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other