Patient's exact age is unknown; however it was reported that the patient was over the age of 18.= initial reporter facility name: (b)(6).(b)(4).Investigation result: a visual examination of the returned complaint device revealed that the balloon did not have any visual defects and was in a good condition.No damage found on the catheter of the device.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole noticed in the middle section of the balloon.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose such as; the manner as the device was handled, and/or the interaction with the scope during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with lithotomy and endoscopic nasobiliary drainage (enbd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that the balloon was leaking.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the balloon found a pinhole; therefore, this is now an mdr reportable event.
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