Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h10: investigation results the returned cre pro wireguided dilatation balloon was analyzed, and a visual examination found that the catheter of the device was kinked.No damages were found to the balloon of the device.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 79 mm from the tip.Microscopic inspection found a pinhole located approximately at 79 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 the balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.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.In addition, it is possible that the catheter may have kinked due to the manipulation or technique used during the procedure.Therefore, the most probable root cause is an adverse event related to procedure.
|