It was reported to boston scientific corporation that an rx cytology brush was used in the bile passage during a cytology procedure.According to the complainant, during the procedure, severe resistance was encountered when extending and retracting the brush into the catheter which make it difficult to obtain tissue.The procedure was completed with this device.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 good.This event has been deemed a reportable event based on the investigation results; wire broke.
|