BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASHER-14

    MDR report key: 191882 · Received October 7, 1998

    Report

    Report Number
    6000078-1998-00136
    Event Type
    Malfunction
    Date Received
    October 7, 1998
    Date of Event
    September 4, 1998
    Report Date
    October 7, 1998
    Manufacturer
    TARGET THERAPEUTICS A BOSTON SCIENTIFIC CO
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TARGET WAS NOTIFIED THAT DURING A "HCC TAE" PROCEDURE THE DISTAL COIL OF THE "GDC" DETACHED IN THE A8 BRANCH OF THE RIGHT HEPATIC ARTERY. THE PT WAS NOT AFFECTED FROM THIS OCCURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASHER-14 GUIDEWIRE DQX TARGET THERAPEUTICS A BOSTON SCIENTIFIC CO NA A61380

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR