Block h6: imdrf device code a0402 captures the reportable event of a 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 balloon burst was not confirmed.The longitudinal tear problem found could have been interpreted by the customer as the reported event of a balloon burst.The longitudinal tear found is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure, interaction with other devices, or anatomical factors.These factors and interactions could influence the damage found in the balloon.Also, it is possible that interaction with any kind of a sharp surface during or previous the procedure could create friction on the balloon, causing the problem of longitudinal tear during the procedure.Therefore, the most probable root cause is an adverse event related to procedure.
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