TY - JOUR
T1 - Balloon dilation complication during the treatment of subglottic stenosis
T2 - Background of the FDA class 1 recall for the 18 x 40-mm acclarent inspira AIR balloon dilation system
AU - Achkar, Jihad
AU - Dowdal, Jayme
AU - Fink, Daniel
AU - Franco, Ramon
AU - Song, Phillip
PY - 2013/6
Y1 - 2013/6
N2 - 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.
AB - 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.
KW - Balloon dilation
KW - Idiopathic subglottic stenosis
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U2 - 10.1177/000348941312200603
DO - 10.1177/000348941312200603
M3 - Article
C2 - 23837387
AN - SCOPUS:84878927002
SN - 0003-4894
VL - 122
SP - 364
EP - 368
JO - Annals of Otology, Rhinology and Laryngology
JF - Annals of Otology, Rhinology and Laryngology
IS - 6
ER -