Note: this report pertains to one of two alliance ii inflation syringe used in the same patient and procedure.It was reported to boston scientific corporation that an alliance ii inflation syringe was attempted to be used during a procedure performed on (b)(6) 2024.During the procedure, the balloon was inflated, however, the pressure gauge was not rising to show the pressure inside the balloon.The same problem occurred with the second alliance ii inflation syringe.The customer reported that gun itself might be the problem and not the complimentary devices.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.
|