RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX CYTOLOGY BRUSH WAS USED FOR CHOLANGIOCARCINOMA IN THE COMMON BILE DUCT DURING A ENDOSCOPIC PANCREATO-CHOLANGIOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE WIRE OF THE BRUSH WAS FOUND TO BE SEPARATED BEFORE USAGE SO IT WAS UNABLE TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: PROBLEM CODE A0401 CAPTURES THE REPORTABLE EVENT OF BRUSH WIRE BREAK. BLOCK H10: INVESTIGATION RESULTS AN RX CYTOLOGY BRUSH WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE BRUSH WAS CAME BACK EXTENDED. THE WORKING LENGTH WAS KINKED AND THERE WERE REMNANTS OF USE. IN ADDITION, THE BLUE KNOB WAS UNSCREWED TO INSPECT THE INTERNAL CONDITION OF THE WIRE AND IT WAS NOTED THAT THE PULL WIRE WAS BROKEN. NO OTHER DEVICE PROBLEMS WERE NOTED. THE REPORTED COMPLAINT OF WIRE BREAK WAS CONFIRMED SINCE THE RESULTS OF THE ANALYSIS PERFORMED ON THE RETURNED PRODUCT SHOWED THAT THE INTERNAL PULL WIRE WAS BROKEN AT THE JUNCTION TO THE HANDLE. IN ADDITION, THE WORKING LENGTH WAS KINKED. THIS SUGGESTS THAT THE MANIPULATION, THE TECHNIQUE USED, OR THE ANATOMICAL CONDITIONS OF THE PATIENT MAY HAVE KINKED THE WORKING LENGTH, SO IT MAY HAVE BEEN NECESSARY TO APPLY A GREATER FORCE WHICH LED TO THE RUPTURE OF THE INTERNAL PULL WIRE. BASED ON THE INFORMATION AVAILABLE AND THE RETURNED DEVICE ANALYSIS, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS ADVERSE EVENT RELATED. THIS IS DEFINED AS THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. BLOCK H11: BLOCK D4 (LOT NUMBER) HAS BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 28, 2022.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED FOR CHOLANGIOCARCINOMA IN THE COMMON BILE DUCT DURING A ENDOSCOPIC PANCREATO-CHOLANGIOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE WIRE OF THE BRUSH WAS FOUND TO BE SEPARATED BEFORE USAGE SO IT WAS UNABLE TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.