RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

INITIAL REPORTER NAME AND ADDRESS: (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING A BILE DUCT SMEAR CYTOLOGY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, DURING AN ATTEMPT TO RETRACT THE BRUSH, THE WIRE BECAME SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING A BILE DUCT SMEAR CYTOLOGY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, DURING AN ATTEMPT TO RETRACT THE BRUSH, THE WIRE BECAME SEPARATED. 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 E1: (INITIAL REPORTER CITY). (B)(6). BLOCK H6: PROBLEM CODE A0401 CAPTURES THE REPORTABLE EVENT OF WIRE BREAK. BLOCL H10: (PRODUCT INVESTIGATION). ONE RX CYTOLOGY BRUSH WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH WAS KINKED, APPROXIMATELY AT 65CM FROM THE BLACK HEAT SHRINK. IN ADDITION, THE DEVICE WAS DISASSEMBLED AND IT WAS OBSERVED THAT THE PULL WIRE WAS BROKEN ADJACENT TO THE HANDLE CANNULA JOINT. NO OTHER ISSUES WERE NOTED. THE REPORTED COMPLAINT WAS CONFIRMED. THE WORKING LENGTH WAS FOUND KINKED/BENT, WHICH COULD BE DUE TO THE AMOUNT OF FORCE APPLIED AND MANIPULATION DURING THE PROCEDURE. IT WAS POSSIBLE THAT THE WAY IN WHICH THE DEVICE WAS HANDLED AND MANIPULATED MAY HAVE CONTRIBUTED TO THE ENCOUNTERED FAILURE (WIRE BREAK). AS PER COMPLAINT INFORMATION THE ISSUE OCCURRED DURING THE PROCEDURE. IT WAS MOST LIKELY THAT PROCEDURAL FACTORS, SUCH AS USER TECHNIQUE/HANDLING OR EXCESS FORCE APPLIED DURING ITS USE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. IN ADDITION, HANDLING AND MANIPULATION OF THE DEVICE DURING THE PROCEDURE CAN LEAD TO THE BROKEN PULL WIRE FROM THE HANDLE CANNULA. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS PROBLEM IS ADVERSE EVENT RELATED TO PROCEDURE SINCE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. 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.