It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a dilation 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 the balloon had to be cut to be able to be removed from the scope.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
|