Block a2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h10: investigation results the returned hurricane rx dilatation balloon was analyzed, and a visual examination found that the balloon was damaged.Microscopic inspection found that the balloon had a longitudinal tear.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of a balloon burst cannot be confirmed.The longitudinal tear problem found in the balloon could have been interpreted by the customer as the reported event of a balloon burst.It is possible that during the procedure, the device has interacted with some sharp surface or other devices that may have caused the longitudinal tear of the balloon.It is possible that the manipulation of the device, technique used, or patient's anatomical conditions could have contributed to the physical damage on the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
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