BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTA OPTA 5F 135CM 7#4

    MDR report key: 269060 · Received March 11, 2000

    Report

    Report Number
    9610978-2000-00051
    Event Type
    Malfunction
    Date Received
    March 11, 2000
    Date of Event
    February 25, 2000
    Report Date
    March 10, 2000
    Manufacturer
    CORDIS EUROPA, N.V. (RODEN)
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON RUPTURED AT 4 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTA OPTA 5F 135CM 7#4 PTA CATHETERS LIT CORDIS EUROPA, N.V. (RODEN) NA S0798104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN