RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

BLOCK E1: THE INITIAL REPORTER ADDRESS IS:(B)(6). BLOCK H6: PROBLEM CODE 1069 CAPTURES THE REPORTABLE EVENT OF WIRE BROKEN. BLOCK H10: INVESTIGATION RESULTS AN RX CYTOLOGY BRUSH WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE PULL WIRE WAS BROKEN AND REMOVED FROM ITS ORIGINAL POSITION. NO OTHER ISSUES WERE NOTED. BASED ON THE EVENT DESCRIPTION, THE PROBLEM WAS NOTICED DURING PROCEDURE AND INSIDE THE PATIENT. IT IS POSSIBLE THAT OPERATIONAL FACTORS SUCH AS USER TECHNIQUE/HANDLING DURING PROCEDURE CONTRIBUTED TO THE OBSERVED PULL WIRE BROKEN. THIS CONDITION COULD HAVE BEEN GENERATED BY MANIPULATION AND/OR ANY FORCE APPLIED BY THE USER TO THE DEVICE. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ADVERSE EVENT RELATED TO PROCEDURE. A RISK REVIEW OF THE BILIARY CYTOLOGY WAS COMPLETED USING (B)(6), RISK ANALYSIS WORKBOOK- BIOPSY BRUSHES, BSC, AV AND CONFIRMED THAT THE EVENT OF WIRE BREAK WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDIION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

Additional Manufacturer Narrative

(B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; 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 IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT "CONDIION" FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.