It was reported to boston scientific corporation that a cre fixed wire balloon was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2015.According to the complainant, during preparation, it was noticed that the balloon did not physically appear normal.They chose not to use the balloon and it was reported that when the balloon was inflated the balloon appeared to be twisted and an irregular shape.The procedure was completed with another cre fixed wire balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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