BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA AIR BALLOON CATHETER

    MDR report key: 3853474 · Received May 28, 2014

    Report

    Report Number
    3005172759-2014-00012
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KTI
    PMA / PMN Number
    K110218
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT MADE ATTEMPT THREE TIMES TO CONTACT THE TREATING PHYSICIAN TO REQUEST ADDITIONAL INFORMATION BUT DID NOT GET ANY RESPONSE. MDR WILL BE UPDATED IF ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE F CAUTION. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(4) 2014 OF AN EVENT DURING AN AIRWAY DILATION CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WERE USED. THE PHYSICIAN WAS IN THE PROCESS OF PERFORMING AN AIRWAY PROCEDURE AND WHILE INFLATING THE BALLOON INTO PATIENT THROAT, HIS CRICOID WAS FRACTURED. PROCEDURE WAS STOPPED AND BALLOON WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312853 INSPIRA AIR BALLOON CATHETER INSPIRA KTI ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other