It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2018. according to the complainant, during the procedure, when the physician attempted to pass the balloon through the device into the biopsy cap, the tip of the balloon kept bending, and was unable to advance through the biopsy cap.The procedure was completed with another cre fixed wire dilatation 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 fine.
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