Initial reporter address: (b)(6).(b)(4).Investigation result: a visual examination of the returned complaint device found that the balloon and catheter did not have any visual defects and was in a good condition.Functional evaluation was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole located at the proximal section of the balloon.This failure is likely due to factors or conditions related to procedure during the use of the device, such as the manner in which the device was handled and manipulated, and/or the interaction between the scope and device, that could have affected its performance and its intended purpose.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.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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It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a leak was noted at the proximal section of the balloon due to a hole.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 had a pinhole; therefore, this is now an mdr reportable event.
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