BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTA OPTA 5F 135CM 7#4

    MDR report key: 201930 · Received December 16, 1998

    Report

    Report Number
    9610978-1998-00092
    Event Type
    Injury
    Date Received
    December 16, 1998
    Date of Event
    November 3, 1998
    Report Date
    December 16, 1998
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING OFF LABEL USE FOR CAROTID ARTERY STENT PLACEMENT, DIFFICULTY WAS EXPERIENCED DEFLATING THE BALLOON. AFTER THE PROCEDURE, THE BALLOON WAS TESTED AND NO BURST WAS FOUND.

    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. NA R0198182

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN