• Ann Oto Rhinol Laryn · Jun 2013

    Case Reports

    Balloon dilation complication during the treatment of subglottic stenosis: background of the FDA class 1 recall for the 18 x 40-mm Acclarent Inspira AIR balloon dilation system.

    • Jihad Achkar, Jayme Dowdal, Daniel Fink, Ramon Franco, and Phillip Song.
    • Massachusetts Eye and Ear Infirmary, Division of Laryngology, Department of Otology and Laryngology, Harvard Medical School, Boston, Massachusetts, USA.
    • Ann Oto Rhinol Laryn. 2013 Jun 1; 122 (6): 364-8.

    ObjectivesBalloon dilation for subglottic stenosis allows for a controlled radial expansion of the airway and is considered superior to older techniques of airway dilation. We report the case of a 39-year-old woman with idiopathic subglottic stenosis who had entrapment of an inflated balloon in her subglottis due to device failure while undergoing balloon dilation of the stenotic area.MethodsWe present a case report and a review of the literature.ResultsAs a result of this and other reported incidents, on March 13, 2012, the US Food and Drug Administration issued a class 1 recall of the 18 x 40-mm Acclarent Inspira AIR Balloon Dilation System (Acclarent Inc, Menlo Park, California).ConclusionsThis is the first report describing a dislodged inflated balloon in the subglottis as a complication of dilation for idiopathic subglottic stenosis. Awareness of this possibility, as well as preparedness with the proper instruments, is vital for prevention of a catastrophic emergency during an otherwise low-risk procedure.

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