RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

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.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO THREE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIREGUIDED WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH FAILED TO EXTEND AND IT WAS NOTED THAT THE BRISTLED PORTION OF THE BRUSH WAS EXTREMELY KINKED. THE PROCEDURE WAS COMPLETED WITH A FOURTH 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.