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, Phillip Song

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)364-368
Number of pages5
JournalAnnals of Otology, Rhinology and Laryngology
Volume122
Issue number6
DOIs
StatePublished - Jun 2013

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Dilatation
Pathologic Constriction
Equipment Failure
Therapeutics
United States Food and Drug Administration
Emergencies

Keywords

  • Balloon dilation
  • Idiopathic subglottic stenosis

ASJC Scopus subject areas

  • Otorhinolaryngology

Cite this

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title = "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",
abstract = "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.",
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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.

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