Document Detail

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.
MedLine Citation:
PMID:  23837387     Owner:  NLM     Status:  In-Process    
OBJECTIVES: Balloon 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.
METHODS: We present a case report and a review of the literature.
RESULTS: As 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).
CONCLUSIONS: This 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.
Jihad Achkar; Jayme Dowdal; Daniel Fink; Ramon Franco; Phillip Song
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Annals of otology, rhinology, and laryngology     Volume:  122     ISSN:  0003-4894     ISO Abbreviation:  Ann. Otol. Rhinol. Laryngol.     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-07-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0407300     Medline TA:  Ann Otol Rhinol Laryngol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  364-8     Citation Subset:  AIM; IM    
Massachusetts Eye and Ear Infirmary, Division of Laryngology, Department of Otology and Laryngology, Harvard Medical School, Boston, Massachusetts, USA.
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