It was reported to boston scientific corporation that an orbera365 intragastric balloon system was used on an intragastric balloon placement procedure used to treat obesity performed on (b)(6) 2023.On (b)(6) 2024, the patient complained of blue colored urine.On (b)(6) 2024, an endoscopy was performed which confirmed the balloon was deflated at which time the deflated balloon was removed.There were no patient complications as a result of this event.It was reported that methylene blue was used when filling the orbera balloon.However, according to the instructions for use (ifu) the igb is places in the stomach and filled with sterile saline.Therefore, ar code 5191:2457: (device use of device issue - user error) has been applied.
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