BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 6002499 · Received October 6, 2016

    Report

    Report Number
    6002499
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 27, 2016
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VALVULOPLASTY BALLOON WAS PREPPED ACCORDING TO STANDARD PREP. BALLOON WAS MANUALLY INFLATED BY THE DOCTOR. BALLOON HELPED ITS NOMINAL SIZE FOR ABOUT 2 SECONDS, THEN BURST. BALLOON WAS IMMEDIATELY PLACED ON NEGATIVE PREP PRESSURE AND BLOOD ENTERED THE BALLOON PORT (INDICATES BALLOON RUPTURE) AND BALLOON WAS WITHDRAWN FROM PATIENT. BALLOON WAS INSPECTED AND BALLOON MATERIAL WAS INTACT. PATIENT STATUS STABLE AFTER EVENT WITH NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660317 TYSHAK II CATHETER, PERCUTANEOUS DQY NUMED, INC. PDC529 TT-11908

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other