Acclarent was informed on (b)(6) 2018, of an event that occurred during the airway dilation procedure on (b)(6) 2018, involving the 14 x 40mm inspira air balloon dilation system (bc1440a / 180817b-pc).It was reported that upon the second dilation, the inspira air balloon could not become fully deflated; this issue was reported to have occurred outside of the patient¿s airway.It was reported that the guide/balloon was not flushed prior to use.The inspira balloon was replaced with another 14 x 40mm inspira air balloon and the procedure was continued and successfully completed with the replacement device.There was no report of any patient consequence or adverse event associated with the issue.The inspira air balloon was reported to have been discarded and is not available to be returned for evaluation.
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