It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, it was noted that there was an issue getting the balloon fully deflated.The device was then removed with scope and had to be cut.The procedure had already been completed with the original device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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