BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDI-TECH 8MM-2CM ULTRATHIN BALLOON CATHETER

    MDR report key: 18792 · Received October 13, 1994

    Report

    Report Number
    18792
    Event Type
    Death
    Date Received
    October 13, 1994
    Date of Event
    September 2, 1994
    Report Date
    September 27, 1994
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A RE-COARCTATION OF THE AORTA WITH A 50 MMHG GRADIENT MEASURED DURING CATHETERIZATION. A BALLOON CATHETER WAS USED TO REDUCE THE GRADIENT TO 4 MMHG. DURING THE PROCEDURE THERE WERE NO NOTED PROBLEMS WITH THE BALLOON CATHETER NOR CONCERNS WITH ITS USE. THE PT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT. APPROX SIX HRS FOLLOWING THE PROCEDURE THE PT HAD A CATASTROPHIC RUPTURE OF THE AORTIC ARCH AND EXPIRED. THE CATHETER HAD NOT BEEN SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TECH 8MM-2CM ULTRATHIN BALLOON CATHETER BALLOON CATHETER LIT MEDI-TECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Congenital Anomaly| D