(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a captivator large oval med stiff snare was used in the stomach during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when trying to remove the target polyp, the snare loop was trapped in the polyp tissue.The snare failed to cut or cauterize the tissue and the snare could not be removed.Reportedly, the snare was securely attached to the active cord and there were no visible issues noted with the cautery pin or the device.An emergent exploratory laparotomy surgery was performed to remove the snare and the procedure was completed.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
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