BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 1731756 · Received June 15, 2010

    Report

    Report Number
    1731756
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    April 14, 2010
    Report Date
    June 15, 2010
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TAKEN TO THE PEDIATRIC CATH LAB FOR CARDIAC CATHETERIZATION AND BALLOON ANGIOPLASTY OF THE PULMONARY ARTERY. DURING THE PROCEDURE, THE CARDIOLOGIST INFLATED THE BALLOON, IT RUPTURED AND WHEN TENSION WAS APPLIED TO REMOVE THE BALLOON, PART OF THE BALLOON BROKE OFF AND COULD NOT BE REMOVED. THE BALLOON TIP EMBOLIZED TO THE LEFT LOWER POSTERIOR PULMONARY ARTERY SMALL DISTAL BRANCH. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS DONE WHICH DEMONSTRATED NO INTRACARDIAC FOREIGN BODIES. THE PATIENT WAS MONITORED IN THE PACU OVERNIGHT AND DISCHARGED THE NEXT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II CATHETER, PERCUTANEOUS DQY NUMED, INC. * TT - 4431 ST-524

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR