BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLARENT AERA

    MDR report key: 6935196 · Received October 10, 2017

    Report

    Report Number
    6935196
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 6, 2017
    Report Date
    September 18, 2017
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PNZ
    UDI-DI
    10705031230880
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PREPARING THE ACCLARENT AERA EUSTACHIAN TUBE BALLOON CATHETER ON THE STERILE BACK TABLE TO BE SURE DEVICE WAS FUNCTIONAL. THE STAFF AND SURGEON NOTED THE BALLOON CATHETER WAS BENT AND THE BALLOON RUPTURED WHEN THE SURGEON BEGAN TO FILL THE BALLOON. COMPANY WAS NOTIFIED IMMEDIATELY AFTER THE CASE ABOUT THE DEFECT. MANUFACTURER RESPONSE: FOR EUSTACHIAN TUBE BALLOON DILATION DEVICE, ACCLARENT AERA (PER SITE REPORTER) MANUFACTURER WAS NOTIFIED AND SEND IN A REPLACEMENT DEVICE. REP WILL PICK UP NEXT TIME AT OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717984 ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION DEVICE PNZ ACCLARENT, INC. EU061655 160505B-PC 10705031230880

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR DEVICE WAS ON THE STERILE BACK TABLE OF THE SURGIC| NO OTHER THERAPIES