RX CYTOLOGY BRUSH

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE STOMACH DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND BILIARY BRUSH EXAMINATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BLUE CAP AT THE END OF THE CYTOLOGY BRUSH DELIVERY DEVICE COULD NOT RETURN TO ITS ORIGINAL POSITION AFTER IT WAS PUSHED OUT, AND THE TIP OF THE BILIARY BRUSH WAS DAMAGED AND HAD A GAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

Additional Manufacturer Narrative

BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6) MEDICAL UNIVERSITY. BLOCK H6: IMDRF A0501 CAPTURES THE REPORTABLE EVENT OF BRUSH DETACHED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE STOMACH DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND BILIARY BRUSH EXAMINATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BLUE CAP AT THE END OF THE CYTOLOGY BRUSH DELIVERY DEVICE COULD NOT RETURN TO ITS ORIGINAL POSITION AFTER IT WAS PUSHED OUT, AND THE TIP OF THE BILIARY BRUSH WAS DAMAGED AND HAD A GAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

Additional Manufacturer Narrative

BLOCK E1 (INITIAL REPORTER FACILITY NAME): (B)(6). BLOCK H6: IMDRF A0501 CAPTURES THE REPORTABLE EVENT OF BRUSH DETACHED. BLOCK H10 INVESTIGATION RESULTS: ONE CYTOLOGY BRUSH WAS RECEIVED FOR ANALYSIS. VISUAL AND MICROSCOPE ANALYSIS OF THE RETURNED DEVICE FOUND THE PULL WIRE WAS KINKED ADJACENT TO THE HANDLE. NO OTHER DEVICE PROBLEMS WERE NOTED. THE REPORTED EVENT OF "BRUSH DETACHED" COULD NOT BE CONFIRMED SINCE THE BRUSH WAS NOT DETACHED. THE PRODUCT RECORD REVIEW CONFIRMED THAT THIS WAS NOT A NEW FAILURE TYPE AND THE RISK WAS ANTICIPATED. THERE WAS NO EVIDENCE OF A MANUFACTURING PROBLEM, DESIGN OR USER PROBLEM WHICH COULD HAVE CAUSED THE COMPLAINT. DEVICE ANALYSIS FOUND THE PULL WIRE WAS KINKED OUTSIDE THE HANDLE DURING VISUAL AND MICROSCOPE TEST. IT IS MOST LIKELY THAT DURING MANIPULATION OF THE DEVICE AN EXCESS OF FORCE WAS APPLIED TO THE DEVICE SUCH AS THE INTERACTION WITH THE SCOPE OR ADDITIONAL TOOLS/MEDICAL DEVICES, CAUSING THE DEVICE TO SEPARATE IN TWO PIECES. THEREFORE, BASED ON ANALYSIS OF THE RETURNED DEVICE AND ALL AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENT IS ADVERSE EVENT RELATED TO PROCEDURE.