BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRA AIR BALLOON

    MDR report key: 1743015 · Received June 25, 2010

    Report

    Report Number
    MW5016535
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    May 10, 2010
    Report Date
    June 25, 2010
    Manufacturer
    ACCLARENT INC.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD TRACHEAL STENOSIS, USED ACCLARENT AIRWAY BALLOON TO DILATE TRACHEAL STRICTURE. BALLOON PLACED, INFLATED AND COULD NOT DEFLATE. PHYSICIAN ENDED UP BREAKING BALLOON WITH TELESCOPE IN ORDER TO DEFLATE BALLOON AND REGAIN AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRA AIR BALLOON DILATING AIRWAY BALLOON KNQ ACCLARENT INC. BC1440A 100219B

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR