BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SHEATH

    MDR report key: 2954020 · Received January 28, 2013

    Report

    Report Number
    2954020
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    A 6FR SHEATH WAS INSERTED INTO THE RIGHT FEMORAL ARTERY. IT WAS NOTICED THAT THE SHEATH HAD A SMALL HOLE IN THE VALVE AREA AFTER IT WAS IN THE PATIENT. UPON PULL BACK IT STARTED SQUIRTING. THE SHEATH WAS THEN REMOVED AND REPLACED WITH ANOTHER ONE OUT OF THE SAME LOT. THE CASE WAS DELAYED DUE TO THIS ISSUE AND PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37109 SUPER SHEATH INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC * 12G18B3

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NO OTHER THERAPIES