BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIB CATHETER

    MDR report key: 370271 · Received January 3, 2002

    Report

    Report Number
    1318694-2001-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2002
    Report Date
    December 21, 2001
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN INFLATING THE INNER BALLOON, THE OUTER BALLOON WAS ALSO INFLATING. THE INNER BALLOON HAD BURST CAUSING THE OUTER BALLOON TO INFLATE WHICH IN TURN CAUSED A STENT TO SHOOT OFF THE END OF THE CATHETER. THE PATIENT HAD TO BE TAKEN TO SURGERY TO REMOVE THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIB CATHETER PTA CATHETER LIT NUMED, INC. CUSTOM ORDERED EER-2207

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN