RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

DATE OF EVENT WAS APPROXIMATED TO BE (B)(6) 2019 AS NO EVENT DATE WAS REPORTED. (B)(6). (B)(4). AN RX CYTOLOGY BRUSH WAS RETURNED FOR ANALYSIS. A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH (EXTRUSION AND PULL WIRE) WAS KINKED IN SEVERAL LOCATIONS. THE HANDLE WAS SEPARATED FROM THE DEVICE. THE PULL WIRE WAS KINKED AND BROKEN ADJACENT TO THE HANDLE CANNULA JOINT. IN ADDITION, THE DISTAL SECTION OF THE PULL WIRE WAS EXTENDED AND IT WAS OBSERVED THAT THE BRUSH SECTION WAS CUT AT DISTAL END, MARKS IN THE CUT ENDS OF THE WIRE INDICATED THAT AN UNKNOWN TOOL WAS USED TO CUT THE DEVICE. FUNCTIONAL INSPECTION WAS PERFORMED AND THE PULL WIRE FAILED TO RETRACT. 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/BROKEN, HANDLE SEPARATED) WERE CAUSED DUE TO MANIPULATION AS THE CUSTOMER BRUSHED BACK AND FORTH DURING PROCEDURE. HANDLING AND MANIPULATION OF THE DEVICE CAN LEAD TO KINKING OF THE EXTRUSION AND PULL WIRE. THIS CONDITION CAN CAUSE DIFFICULTIES TO EXTEND/RETRACT THE BRUSH. FORCE APPLIED TO THE HANDLE IN ORDER TO EXTEND/RETRACT THE BRUSH CAN RESULT IN KINKING THE PULL WIRE AT HANDLE CANNULA JOINT, ALSO CONTINUED MOVEMENTS OF THE HANDLE TO EXTEND/RETRACT THE BRUSH CAN RESULT IN PULL WIRE BREAKAGE AND CONSEQUENTLY THE HANDLE SEPARATION FROM THE DEVICE. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE IS "ADVERSE EVENT RELATED TO PROCEDURE." 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 WIREGUIDED WAS USED IN THE BILE DUCT DURING A CYTOLOGY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER SCRAPING WAS PERFORMED AND WHEN THE BRUSH WAS RETRACTED INTO THE CATHETER, THE BRUSH WAS UNABLE TO RETRACT. 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 WIRE WAS BROKEN.