Analysis of Reported Balloon Malfunctions and Proposed Rescue Strategy for Malfunction during Airway Dilation.

Abstract

Objective The rate of balloon dilator failure is unknown, and a rescue strategy for device malfunction has not been established. The purposes of this investigation were to determine the approximate number of balloon failures in the gastrointestinal tract and airway, evaluate the parameters required to rupture balloon dilators, and develop a rescue strategy to efficiently reestablish airway patency. Study Design Retrospective cohort and basic medical research. Setting Academic tertiary care medical center. Subjects and Methods The Manufacturer and User Facility Device Experience database was queried for adverse events associated with tracheal and esophageal dilators between January 1, 2014, and January 1, 2017. A bench-top model of airway stenosis was developed, and optimal conditions for the safe removal of a malfunctioning dilator were assessed (2, 4, 6 atm). Results There were 420 reported balloon malfunctions, including 104 cases with deflation/removal issues. The bench-top model determined that device rupture allowing for immediate removal occurs with needle puncture at balloon pressures ≥8 atm. Balloons inflated to 6 atm required a median of 17.5 seconds (range, 0-55.3) for removal, in comparison with 30.2 seconds (range, 7.1-87.5) at 2 atm ( P > .05). Conclusion Balloon dilator malfunction is a significant problem that practitioners must be prepared for. Pressure ≥8 atm (~33% overinflation) is required to consistently cause complete balloon dilator rupture via needle puncture. While counterintuitive, increasing the inflation pressure of a malfunctioning balloon (8-10 atm) may expedite rupture and safe removal. A rescue strategy for balloon malfunction is proposed.