BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM BALLOON CATHETER

    MDR report key: 34228 · Received July 18, 1996

    Report

    Report Number
    MW1009503
    Event Type
    Malfunction
    Date Received
    July 18, 1996
    Date of Event
    June 26, 1996
    Report Date
    July 9, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BALLOON RUPTURED AFTER SEVERAL DILATATIONS, LAST DILATATION AT 13 ATM. SMALL PIECE OF BALLOON MATERIAL REMAINED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM BALLOON CATHETER PTCA CATHETER LOX ADVANCED CARDIOVASCULAR SYSTEMS, INC. 602251

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other