BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 6766538 · Received August 4, 2017

    Report

    Report Number
    6766538
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 25, 2017
    Report Date
    August 2, 2017
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PRE-DILATATION THE BALLOON RUPTURED AND WAS REMOVED BUT IT HAD SEPARATED FROM THE INNER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548018 TYSHAK II CATHETER, PERCUTANEOUS DQY B BRAUN INTERVENTIONAL SYSTEMS, INC TT-11961

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR NO OTHER THERAPIES.| NO,