BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROVASIVE CRE WIREGUIDED ESOPH/PYL BALLOON 12-13.5-15

    MDR report key: 726120 · Received May 25, 2006

    Report

    Report Number
    MW1039352
    Event Type
    Death
    Date Received
    May 25, 2006
    Date of Event
    May 11, 2006
    Report Date
    May 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD
    Product Code
    KNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FEMALE WITH TRACHEAL STENOSIS Y STENT - PATIENT WITH PERSISTENT DYSPNEA PRESENTED FOR BALLOON TRACHEOSTOMY. UNDER GENERAL ANESTHESIA, PATIENT WAS BRONCHOSCOPED WITH VISUALIZATION OF SUB GLOTTIC STENOSIS. THE BALLOON WAS INFLATED, THE PATIENT EXPERIENCED DESATURATION, LOW HEART RATE AND HYPERTENSION. DECISION MADE TO REMOVE CATHETER. WHEN REMOVED, BALLOON SEPARATED FROM CATHETER. THE PATIENT WAS INTUBATED WITH RIGID BRONCHOSCOPE WITH REMOVAL OF DEFLATED BALLOON. THE PATIENT REQUIRED EPHEDRINE, ATROPINE, EPINEPHRINE AND VENTILATION. THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT HAD AN MI, ISCHEMIC HEPATITIS, RENAL FAILURE AND DECREASING HCT. THE PATIENT DEVELOPED PROGRESSIVE ORGAN FAILURE & EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE CRE WIREGUIDED ESOPH/PYL BALLOON 12-13.5-15 * KNQ BOSTON SCIENTIFIC CORK LTD 5035 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death