BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOPLASTY BALLOON

    MDR report key: 20626 · Received February 7, 1995

    Report

    Report Number
    20626
    Event Type
    Malfunction
    Date Received
    February 7, 1995
    Date of Event
    January 31, 1995
    Report Date
    February 7, 1995
    Manufacturer
    SCIMED LIFE SYSTEMS
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON CATHETER BROKE AT THE SEGMENT THAT COMES OUT OF Y-ADAPTER (PROXIMAL SEGMENT OF CATHETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOPLASTY BALLOON ANGIOPLASTY BALLOON LIT SCIMED LIFE SYSTEMS 431958

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other