Imdrf code a04 captures the reportable event of balloon damage.Investigation results the returned cre pro gi wireguided dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure due to a pinhole in the balloon (distal section), located approximately 12 mm from the tip.Microscopic inspection found a pinhole located approximately at 12 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon damaged was confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon damaged.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
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