(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 ii-10mm round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when attempting to retract the snare into the catheter, the snare loop broke.The procedure was completed with another captivator snare.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 fine.
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