BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKRO-TIP CATHETER PRESSURE TRANSDUCER

    MDR report key: 228243 · Received June 14, 1999

    Report

    Report Number
    1625382-1999-00004
    Event Type
    Malfunction
    Date Received
    June 14, 1999
    Date of Event
    April 15, 1999
    Report Date
    June 10, 1999
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE GUIDEWIRE WAS FOUND STUCK INSIDE THE SPC-464E LUMEN. THE SHAPE HAS BEEN DEFORMED WITH FORCE, BUT STILL COULD NOT PULL THE GUIDEWIRE AWAY FROM THE SPC-464E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIKRO-TIP CATHETER PRESSURE TRANSDUCER ANGIOGRAPHIC CATHETER WITH SINGLE PRESSURE DXO MILLAR INSTRUMENTS, INC. SPC-464E L011518

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other