BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGRAPHIC CATHETER

    MDR report key: 15231 · Received January 24, 1994

    Report

    Report Number
    2247092-1993-00002
    Event Type
    Malfunction
    Date Received
    January 24, 1994
    Date of Event
    November 2, 1993
    Report Date
    November 15, 1993
    Manufacturer
    NOVA MEDICAL SPECIALTIES
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "BALOON APPEARED TO HAVE BURST IN THE HEART. WHEN CATHETER WAS WITHDRAWN, THERE WAS NO EVIDENCE OF THE BALLOON. PROBABLY STILL IN PATIENT." AS QUOTED FROM INITIAL REPORTER. SEE SECTION E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGRAPHIC CATHETER BERMAN TYPE ANGIOGRAPHIC CATHETER DQO NOVA MEDICAL SPECIALTIES K55/43 M358360

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other