BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYSHAK MINI

    MDR report key: 390422 · Received April 26, 2002

    Report

    Report Number
    1318694-2002-00001
    Event Type
    Other
    Date Received
    April 26, 2002
    Date of Event
    March 19, 2002
    Report Date
    April 25, 2002
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON BURST. PHYSICIAN NOTICED THAT A DISTAL PORTION OF THE BALLOON WAS DETACHED CIRCUMFERENTIALLY ON THE X-RAY AT THE TIME OF THE BALLOON BURST. HE COULD NOT FIND THE DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK MINI PTV CATHETER LIT NUMED, INC. 107 TYM-0093

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention