BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIPSE ANGIOPLASTY BALLOON CATHETER, 3.0

    MDR report key: 11479 · Received February 15, 1994

    Report

    Report Number
    MW1000740
    Event Type
    Malfunction
    Date Received
    February 15, 1994
    Date of Event
    December 20, 1993
    Report Date
    December 22, 1993
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON RUPTURE AT 8 ATM DURING ANGIOPLASTY. RATED BURST PRESSURE PER MFR IS 8 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELIPSE ANGIOPLASTY BALLOON CATHETER, 3.0 LOX ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3101852

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other