The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(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 wireguided was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the brush would not completely retract inside the catheter and it was noted that there was a small kink on the bristled portion of the brush.The procedure was completed with another rx cytology brush.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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