It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the bristled portion bent when the brush was advanced.Samples were successfully obtained with this device.When they attempted to put the samples into the container, the brush failed to extend.After several attempts of pushing and pulling, the handle broke.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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