Block h6: device code a1401 captures the reportable event of balloon failure to deflate.Block h6: device code a140101 captures the reportable event of balloon failure to deflate.Block h10: investigation result the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon was torn circumferentially.The catheter of the device was kinked.It was also noticed that the tip of the device was detached and not returned.Microscopic inspection found the balloon was torn circumferentially with irregular edges and the tip of the device was detached with evidence of a mechanical cut.A functional inspection could not be performed due to the returned condition of the device.No other problems with the device were noted.It was reported that the balloon could not be deflated during the procedure but, this could not be confirmed as the balloon was torn circumferentially and a functional analysis was not possible.A circumferential tear does not allow inflation of the balloon.It is possible that factors encountered during the procedure, such as the excess pressure, interaction with other devices, or anatomical affairs could cause physical damage to the balloon.It is possible that interaction with any surface during the procedure could create friction on the balloon, causing it to tear circumferentially during the procedure.Also, it is possible that interaction with any kind of a sharp surface during or previous to the procedure could create friction on the balloon, causing the balloon to be torn circumferentially.Therefore, the most probable root cause of the balloon failing to deflate is cause not established.
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