It was reported to boston scientific that an orbera365 intragastric balloon system was used in an intragastric balloon implantation procedure on (b)(6) 2022.During the scheduled endoscopic removal procedure on (b)(6) 2024, no balloon was in situ.There were no patient complications as a result of this event.Note: 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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