BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 6759641 · Received August 2, 2017

    Report

    Report Number
    6759641
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 12, 2017
    Report Date
    July 31, 2017
    Manufacturer
    B. BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT USED FOR BALLOON ANGIOPLASTY: TYSHAK II 20MM/4MM LOT #TT-12503, RUPTURED BALLOON. EQUIPMENT RETRIEVED WITH SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542722 TYSHAK II CATHETER, PERCUTANEOUS DQY B. BRAUN INTERVENTIONAL SYSTEMS, INC 611932 TT-12503

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR