BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-MED II X

    MDR report key: 3126558 · Received April 23, 2013

    Report

    Report Number
    3126558
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 23, 2013
    Manufacturer
    B. BRAUN INTERVENTIONAL SYSTEMS INC.
    Product Code
    OZT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    BALLOON WAS DILATED TO 12 ATMOSPHERES (ATM) IN THE LEFT PULMONARY ARTERY. BALLOON WAS FULLY DEFLATED AND PULLED BACK TO BE REMOVED THROUGH THE SHEATH. BALLOON COULD NOT BE PULLED BACK THROUGH SHEATH. SHEATH AND BALLOON CATHETER HAD TO BE REMOVED SIMULTANEOUSLY THROUGH EXISTING PERCUTANEOUS RIGHT FEMORAL VENOUS ACCESS. NO HARM TO PATIENT.======================MANUFACTURER RESPONSE FOR Z-MED 11 - X BALLOON DILATATION CATHETER, B. BRAUN INTERVENTIONAL SYSTEMS INC. (PER SITE REPORTER).======================NONE AS OF THIS DATE AS THEY DO NOT HAVE THE DEVICE AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MEASURE PRESSURES WITHIN THE PULMONARY ARTERIES OF THE HEART.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175784 Z-MED II X CATHETER, ANGIOPLASTY OZT B. BRAUN INTERVENTIONAL SYSTEMS INC. PDZ710 ZZX-1289-1 ST - 76

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR