Note: this report pertains to two cre pro wireguided dilatation balloon that were used in the same patient and procedure.It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used an unknown procedure performed on (b)(6) 2023.During the procedure, while the pediatric consultant and registrar performing gastroscopy, they were unable to feed through the dilatation catheter due to a faulty tip.The procedure was completed using an alternate device.No patient complications have been reported as a result of the event.
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