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 (b)(6), 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 was kinked.Microscopic examination was performed and found that the catheter was kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter break was not confirmed.It was found that the catheter was kinked, not separated, or broken.Excessive manipulation of the device without enough care, excessive force during handling or usage, and/or forcing the device against significant resistance could induce device damages or loss of functionality.As the catheter break was not confirmed, the most probable root cause is no problem detected.
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