It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on august 14, 2023.During the procedure, the catheter broke into two separate pieces making it difficult to remove the balloon.The customer stated that no pieces of the device detached inside the patient.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications as a result of this event.
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Block h6: imdrf device code a0401 captures the reportable event of balloon catheter break.Block h10: investigation results the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the catheter of the device returned split in two pieces and was kinked.Microscopic examination was performed and found that the catheter has evidence of a mechanical cut, and the catheter was accordioned.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter break was confirmed.It was found that the catheter of the device returned split in two pieces, kinked, and accordioned.Also, the detached sections of the catheter have evidence of a mechanical cut.This condition may have occurred due to the manipulation by the physician during the procedure, or if the physician could not remove the device from the scope and was forced to cut the catheter and push the balloon out of the distal tip of the endoscope.Therefore, the most probable root cause is adverse event related to procedure.
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