Note: this report pertains to one of two hurricane rx dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two hurricane rx dilatation balloons were used in the distal common hepatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was noted that the first balloon burst at 12 psi after being advanced through the duodenoscope into the common hepatic duct and inflate.Additionally, the same problem occurred on the second hurricane rx dilatation balloon which also burst at 11 psi.The customer stated that no pieces of the balloons detached inside the patient.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.
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Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h10: investigation results the returned hurricane rx 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 two pinholes in the distal section.Microscopic inspection found the balloon had two pinholes located approximately 9 mm and 30mm 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 burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.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.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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Note: this report pertains to one of two hurricane rx dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two hurricane rx dilatation balloons were used in the distal common hepatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was noted that the first balloon burst at 12 psi after being advanced through the duodenoscope into the common hepatic duct and inflate.Additionally, the same problem occurred on the second hurricane rx dilatation balloon which also burst at 11 psi.The customer stated that no pieces of the balloons detached inside the patient.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.
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