It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the brush was able to advance until the end of the endoscope.However, it got stuck at the elevator, causing the bristled portion of the brush to bend.It was reported that the catheter bent as well.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4) for the reported event of brush bent.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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