BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW

    MDR report key: 643480 · Received October 28, 2005

    Report

    Report Number
    643480
    Event Type
    Death
    Date Received
    October 28, 2005
    Date of Event
    October 26, 2005
    Report Date
    October 27, 2005
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A PEDIATRIC DIAGNOSTIC CATH PROCEDURE, THE BALLOON INFLATED WITH CO2, RUPTURED, EKG SHOWED ISCHEMIC CHANGES, FOLLOWED BY RESPIRATORY DIFFICULTY, BRADICARDIA, DECREASED BP AND PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW BALLOON WEDGE PRESSURE CATHETER EZL ARROW INTERNATIONAL 5FR. 60 CM MF4126927

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Death