BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX STREAK 0.14-2.25 BALLOON CATHETER

    MDR report key: 11394 · Received February 9, 1994

    Report

    Report Number
    MW1000687
    Event Type
    Malfunction
    Date Received
    February 9, 1994
    Date of Event
    January 1, 1994
    Report Date
    January 23, 1994
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON CATHETER RUPTURED 1-1 1/2" PROXIMAL TO BALLOON. BALLOON ITSELF DID NOT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX STREAK 0.14-2.25 BALLOON CATHETER LOX ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3060751

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other