Date of event was approximated to be (b)(6) 2019 as no event date was reported.(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 an rx cytology brush was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, the device was difficult to insert through the scope and it was noted that the brush was bent and kinked when passing brush through scope.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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