BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAWIND

    MDR report key: 3111469 · Received May 8, 2013

    Report

    Report Number
    MW5030110
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MICRUS
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAD A 3 X 4 DELTAPLUSH COIL THAT CAME OUT OF THE CATHETER WHILE FLUSHING IT BEFORE ENTERING THE PT. WE ALSO HAD A 2 X 2 DELTAPLUSH COIL THAT WOULD NOT DETACH IN THE ANEURYSM WHILE IN THE PT. WE CHANGED DETACHMENT BOXES AND CONNECTING CABLES AND IT STILL DID NOT WORK. WE ENDED UP USING ANOTHER COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202254 DELTAWIND COIL HCG MICRUS CPD100304-30 G15512
    202255 DELTAWIND COIL HCG MICRUS CPL100202-30 G15758

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR