RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

(B)(4). AN RX CYTOLOGY BRUSH WAS RETURNED FOR EVALUATION. A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH (EXTRUSION AND PULL WIRE) WAS KINKED IN SEVERAL LOCATIONS. THE HANDLE WAS KINKED AND BROKEN (THUMB RING SEPARATED FROM HANDLE CANNULA AND IT WAS NOT RETURNED WITH THE DEVICE). THE BROKEN END HAS EVIDENCE OF BENDING. A FUNCTIONAL INSPECTION WAS PERFORMED, WHEN THE HANDLE CANNULA WAS MOVED SIMULATING THE HANDLE ACTUATION AND FOUND THAT 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/EXTRUSION KINKED, PULL WIRE BROKEN, HANDLE KINKED/BROKEN) WERE CAUSED DUE TO EXCESSIVE MANIPULATION AS THE CUSTOMER BRUSHED BACK AND FORTH DURING PROCEDURE. HANDLING AND MANIPULATION OF THE DEVICE DURING ITS USE CAN LEAD TO KINKING OF 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 OF THE HANDLE AND KINKING OF THE PULL WIRE AT HANDLE CANNULA JOINT. ALSO CONTINUED MOVEMENTS OF THE HANDLE CAN RESULT IN HANDLE AND 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 DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH WOULD NOT EXTEND FROM THE CATHETER. IT WAS ALSO NOTED THAT THE HANDLE WAS COMPLETELY BROKEN. THE PROCEDURE WAS COMPLETED WITH A THIRD 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.