RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2018 AS NO EVENT DATE WAS REPORTED. (B)(4). A VISUAL ANALYSIS REVEALED THAT THE WORKING LENGTH (EXTRUSION AND PULL WIRE) WAS KINKED IN SEVERAL LOCATIONS. THE HANDLE WAS KINKED. A FUNCTIONAL EVALUATION WAS PERFORMED AND REVEALED THAT WHEN THE HANDLE WAS ACTUATED, THE BRUSH WAS UNABLE TO EXTEND. THE DEVICE WAS DISASSEMBLED AND IT WAS OBSERVED THAT THE PULL WIRE WAS KINKED AND BROKEN ADJACENT TO THE HANDLE CANNULA JOINT. IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING PROCEDURE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. LIKELY THE FAILURES FOUND (PULL WIRE/CATHETER KINKED, PULL WIRE BROKEN, HANDLE KINKED) WERE CAUSED DUE TO EXCESSIVE MANIPULATION AS THE CUSTOMER BRUSHED BACK AND FORTH DURING PROCEDURE. HANDLING AND MANIPULATION OF THE DEVICE CAN LEAD TO KINK THE CATHETER AND PULL WIRE, THIS CONDITION CAN CAUSE DIFFICULTIES TO EXTEND THE BRUSH, EXCESSIVE FORCE APPLIED TO THE HANDLE IN ORDER TO EXTEND THE BRUSH CAN RESULT IN BENDING THE HANDLE AND KINKING THE PULL WIRE AT HANDLE CANNULA JOINT, ALSO CONTINUED MOVEMENTS OF THE HANDLE CAN RESULT IN PULL WIRE BREAKAGE. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE IS "CAUSE TRACED TO COMPONENT FAILURE." A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION.

Description of Event or Problem

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) WITH COMMON BILE DUCT BRUSHING PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH FAILED TO EXTEND AND THE HANDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE PULL WIRE WAS BROKEN.