BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCI-MED

    MDR report key: 116013 · Received June 27, 1997

    Report

    Report Number
    116013
    Event Type
    Malfunction
    Date Received
    June 27, 1997
    Date of Event
    April 2, 1997
    Report Date
    April 8, 1997
    Manufacturer
    BOSTON SCIENTIFICS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING REPEAT CORONARY ANGIOGRAPHY. AN ULTRACROSS 3.2 30 MHX CORONARY IMAGING CATHETER WAS TESTED PRIOR TO INSERTION AND IT PERFORMED PROPERLY. THE CATHETER WAS SUBSEQUENTLY INSERTED INTO THE RCA, FLUSHED AND TURNED ON. THE CATHETER FAILED TO PROVIDE AN IMAGE; IT WAS REMOVED AND REPLACED WITH A 2.9 CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCI-MED ULTRACROSS CORONARY IMAGING CATHETER DQO BOSTON SCIENTIFICS 3.2 30 MHX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR