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 DISTAL SECTION (BRISTLE SECTION) WAS KINKED. A FUNCTIONAL INSPECTION WAS PERFORMED AND FOUND THAT THE BRUSH COULD BE EXTENDED WITHOUT ANY ISSUES. HOWEVER, THE BRUSH WAS NOT ABLE TO BE RETRACTED DUE TO THE KINKED AT THE BRISTLE SECTION. THE BRUSH OUTER DIAMETER WAS ALSO MEASURED TO BE WITHIN SPECIFICATIONS. THE FAILURE FOUND (BRUSH KINKED) WAS LIKELY DUE TO EXCESSIVE MANIPULATION AS THE CUSTOMER BRUSHED BACK AND FORTH DURING THE PROCEDURE. HANDLING AND MANIPULATION OF THE DEVICE CAN LEAD TO KINK THE BRUSH AT DISTAL END, THIS CONDITION WOULD CAUSE DIFFICULTIES TO ADVANCE THE DEVICE THROUGH THE SCOPE. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, IT WAS CONCLUDED THAT THE INVESTIGATION CONCLUSION CODE FOR THIS EVENT IS "CAUSED TRACED TO COMPONENT FAILURE" SINCE THE FAILURE WAS AN EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. 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 FOR AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN IT WAS BEING PASSED OVER A WIRE, THE BRUSH WAS BENT UP AND THE DEVICE WAS DIFFICULT TO ADVANCE THROUGH THE SCOPE. 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 BRUSH (BRISTLE SECTION) WAS BENT.