H10: block h6: imdrf device code a140101 captures the reportable event of the balloon would not deflate.Block h10: investigation results: the returned hurricane rx dilatation balloons 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 distal section approximately 16 mm from the tip of the balloon.Microscopic inspection found the balloon had two pinholes located approximately 16mm and 18mm 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 would not deflate was not confirmed.The pinholes found in the balloon are likely to have occurred due to factors encountered during the procedure: excess pressure, interaction with other devices, or patient anatomy.It is possible that factors encountered during the procedure, such as the interaction with any kind of sharp surface could create friction on the balloon and cause physical damage.Therefore, the most probable root cause is adverse event related to procedure.Labeling review: a labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
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