BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR 1018 MICROCATHETER

    MDR report key: 554072 · Received May 26, 2004

    Report

    Report Number
    6000078-2004-00078
    Event Type
    Malfunction
    Date Received
    May 26, 2004
    Date of Event
    April 19, 2004
    Report Date
    May 25, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED THAT WHEN THE PHYSICIAN OPENED THE PACKAGE OF THE EXCELSIOR 1018 MICROCATHETER, A GDC 10-ULTRASOFT STRETCH RESISTANT COIL, PART NUMBER 343204, AND LOT NUMBER 6327173, WAS FOUND INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR 1018 MICROCATHETER INFUSION CATHETER DQO BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION * 6318294

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO