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)(4). A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH (EXTRUSION AND PULL WIRE) WAS KINKED IN SEVERAL LOCATIONS. THE DISTAL SECTION OF THE WIRE, WHERE THE BRUSH WAS SUPPOSED TO BE LOCATED WAS EXTENDED WHEN RECEIVED. THE DISTAL SECTION OF THE DEVICE (BRISTLE SECTION) WAS CUT AND IT WAS NOT RETURNED FOR ANALYSIS. THE CUT END WAS VISUALLY INSPECTED UNDER MAGNIFICATION AND IT HAS DRAG MARKS AND A CLEAN CUT LIKELY MADE WITH A SHARP TOOL. A FUNCTIONAL INSPECTION WAS PERFORMED AND REVEALED THAT WHEN THE HANDLE WAS ACTUATED, THE DISTAL END OF THE WIRE WAS UNABLE TO BE RETRACTED. THE DEVICE WAS DISASSEMBLED AND IT WAS OBSERVED THAT THE PULL WIRE WAS KINKED ADJACENT TO THE HANDLE CANNULA JOINT. IN ADDITION, THE PULL WIRE WAS BROKEN. IT IS MOST LIKELY THAT THE FAILURES FOUND (PULL WIRE/CATHETER KINKED, PULL WIRE BROKEN) WERE CAUSED DUE TO EXCESSIVE MANIPULATION AS THE CUSTOMER BRUSHED BACK AND FORTH DURING PROCEDURE. HANDLING AND MANIPULATION OF THE DEVICE CAN LEAD TO KINKING OF THE CATHETER AND PULL WIRE. THIS CONDITION CAN CAUSE DIFFICULTIES TO EXTEND/RETRACT THE BRUSH, EXCESSIVE FORCE APPLIED TO THE HANDLE IN ORDER TO EXTEND/RETRACT THE BRUSH CAN RESULT IN KINKING OF THE PULL WIRE AT THE HANDLE CANNULA JOINT, ALSO CONTINUED MOVEMENTS OF THE HANDLE IN ORDER TO EXTEND/RETRACT THE BRUSH 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) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH WAS EXTENDED INTO THE DUCT AND OUT OF THE CATHETER. HOWEVER, THE BRUSH FAILED TO RETRACT BACK INTO THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE PULL WIRE WAS BROKEN.