It was reported to boston scientific corporation that a trapezoid rx was used in the intrahepatic bile duct during an intrahepatic bile duct lithotomy procedure performed on (b)(6) 2023.During the procedure, the outer sheath of the device was found damaged when it was taken out and operated in the patient.A photograph of the device was provided by the customer, and it was observed that the sheath was torn at the proximal section.Another trapezoid rx was used to complete the procedure.There were no patient complications as a result of this event.Note: this event has been deemed a reportable event based on the investigation finding of side car rx push back.Please see block h10 for full investigation details.
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Block h6: imdrf device code a0406 captures the reportable investigation finding of side car rx push back.Block h10: the returned trapezoid rx was analyzed, and a visual inspection found that the side car rx was pushed back.Additionally, the sheath was buckled, torn and detached.A photo submitted also noted the sheath was detached.The reported event was confirmed.Based on all available information, the excessive force used when resistance was encountered might have resulted in damaging some of the components on the device such as the side car rx and outer sheath.These problems could have occurred due to excessive manipulation when operating the basket.Perhaps the technique used, or the patient's anatomical conditions could have contributed to this event.Therefore, the most probable root cause is adverse event related to procedure.
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