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. (B)(6). (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

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY WIREGUIDED BRUSH WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS INSERTED IN THE ENDOSCOPE AND CYTOLOGY WAS PLANNED TO BE PERFORMED. IT WAS NOTICED ON THE ENDOSCOPE SCREEN THAT THE CATHETER TIP WAS DAMAGED. THE DEVICE WAS INSERTED INTO THE BILE DUCT ONCE, AND WAS REPORTED TO BE DIFFICULT TO EXTEND AND RETRACT. TO PREVENT THE RISK OF BILE DUCT INJURY, THE DEVICE WAS REMOVED FROM THE PATIENT. EXAMINATION OF THE DEVICE WAS DONE OUTSIDE OF THE ENDOSCOPE AND THE DEVICE WAS ABLE TO EXTEND AND RETRACT BUT THE CATHETER TIP WAS NOTICED TO BE SLIGHTLY FLATTENED, AND THERE SEEMED TO BE A PART OF THE DISTAL TIP MISSING FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. CONFIRMATION WAS RECEIVED FROM THE NURSE STATING THAT THE MISSING PART WAS NOT INSIDE OF THE PATIENT NOR WAS IT INSIDE THE STERILE BAG THAT THE DEVICE WAS PACKED IN. REPORTEDLY, THE CATHETER TIP MISSING WAS NOTED SOON AFTER THE DEVICE EXCITED OUT OF THE DISTAL TIP OF THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.