Acclarent was informed on 01/11/2018, of an event involving an inspira air balloon dilation system, 16 x 40 mm (lot# unavailable), that was used during an airway dilation procedure that took place approximately 3 to 4 months before that was thought to have been reported to acclarent.Per the discussion on the phone from the acclarent medical director with the physician who performed the procedure, the procedure was to treat a subglottic stenosis using a 14 or 16 mm inspira air balloon.The physician was not able to recall the exact size of the balloon and the balloon has since been discarded.The event reported was the inspira air balloon appeared to have partially separated from the shaft of the catheter and there was difficulty in deflating the balloon.The balloon deflation was achieved by being punctured in the airway using a long-handled knife.The balloon was carefully retrieved from the airway.The patient was reported to have achieved some dilation and did not require any additional surgical intervention.The patient did not suffer any adverse event associated with the reported event.
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