Acclarent was informed on (b)(4) 2017, for an event that occurred on (b)(6) 2017 involving a relieva spinplus kit, 3 guides, 6mm, 5pk (lot# not available).During a primary balloon sinuplasty procedure, while the balloon catheter was being advanced into the left frontal sinus, the blue tapered tip of the balloon catheter separated and fell into the ostiomeatal complex.The separated tip was retrieved by suction.There was no report of any patient consequence.Another device was opened and the procedure was resumed.No non-acclarent devices were used.
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