RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, 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 BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BRUSH DID NOT RELEASE OUT OF THE CATHETER AND HANDLE WAS KINKED DUE TO PRESSURE APPLIED. THE PROCEDURE WAS ABORTED BUT THE PATIENT WAS SEDATED. THE REASON FOR THE ABORTED PROCEDURE IS THERE WAS NO POSSIBILITY TO ACQUIRE CELLS DUE TO UNFUNCTIONAL BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE. BLOCK H10 INVESTIGATION RESULTS: ONE RX CYTOLOGY BRUSH WAS RECEIVED FOR ANALYSIS. VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THE WORKING LENGTH AND HANDLE WERE KINKED. FUNCTIONAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE BRUSH COULD NOT BE EXTENDED; THE HANDLE WAS DISASSEMBLED AND IT WAS NOTED THAT THE INTERNAL PULL WIRE WAS KINKED AT THE JUNCTION TO THE HANDLE. THIS PART OF THE PULL WIRE BELONGS TO THE WORKING LENGTH AND IS CONSIDERED AS WORKING LENGTH KINKED. IN ADDITION, THE DEVICE EXCEEDED THE PERIOD OF TIME/DATE RECOMMENDED BY THE MANUFACTURER FOR STORING THE DEVICE. NO OTHER PROBLEMS WERE NOTED. THE REPORTED COMPLAINT OF "DEVICE SHELF LIFE EXCEEDED" WAS CONFIRMED SINCE THE DEVICE EXCEEDED THE PERIOD OF TIME/DATE RECOMMENDED BY THE MANUFACTURER FOR STORING THE DEVICE WITHOUT A DEGRADATION IN QUALITY. THEREFORE, SHELF LIFE/EXPIRATION DAY EXCEEDED WAS SELECTED AS THE CONCLUSION CODE OF THE REPORTED ISSUE. THE REPORTED EVENT OF "BRUSH DIFFICULT TO EXTEND" WILL BE DOCUMENTED UNDER THE CODE "WORKING LENGTH BENT/KINKED" AND THIS CODE WILL ADDRESS THE PULL WIRE KINKED AS WELL. IT WAS POSSIBLE THAT DUE TO THE TORTUOSITY OR ANATOMY OF THE PATIENT TO WHICH THE UNIT COULD HAVE BEEN EXPOSED AND CONSEQUENTLY CAUSING THE WORKING LENGTH KINKED. IN ADDITION, IT WAS POSSIBLE THAT SOME MANIPULATION DURING THE PROCEDURE AND/OR EVEN THE TECHNIQUE APPLIED WHILE EXTENDING THE BRUSH MAY HAVE CAUSED THE USER ON KINKING THE HANDLE CANNULA AND AS A CONSEQUENCE THE BRUSH WOULDN'T BE ABLE TO EXTEND PROPERLY. BOSTON SCIENTIFIC MANUFACTURING PROCESSES INCLUDE EXTENSIVE INSPECTIONS TO ENSURE THAT ALL FINISHED DEVICES MEET SPECIFICATIONS, THERE ARE CONTROLS IN PLACE TO AVOID THAT A DEVICE LEAVES THE MANUFACTURING PLANT WITH A DEFECT AS THE ONE OBSERVED ON THE DEVICE. ACCORDING TO PROCEDURE, DURING MANUFACTURING FULL LENGTH OF THE DEVICE IS INSPECTED FOR KINKS PER COSMETIC INSPECTION PROCEDURE, ALSO IT WAS CONFIRMED THAT THE BRUSH EXTENDS AND RETRACT PROPERLY, IF THE UNIT DOES NOT EXTEND/RETRACT, IT IS SCRAPPED. THESE STEPS OF THE PROCESS WOULD HAVE DETECTED THE ENCOUNTERED ISSUES. BASED ON THE INFORMATION AVAILABLE AND THE RETURNED DEVICE ANALYSIS, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE. THIS IS DEFINED AS THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS NOT USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. THE IFU DOES NOT ADDRESS THE SHELF-LIFE, HOWEVER, IT DOES CONTAIN THE STEPS NEEDED FOR THE CORRECT USE OF THE DEVICE. THE IFU STATES, "DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. THE USE BY DATE IS DISPLAYED ON THE PRODUCT LABEL". THIS DEVICE WAS USED AFTER THE EXPIRATION DATE. 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 BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BRUSH DID NOT RELEASE OUT OF THE CATHETER AND HANDLE WAS KINKED DUE TO PRESSURE APPLIED. THE PROCEDURE WAS ABORTED BUT THE PATIENT WAS SEDATED. THE REASON FOR THE ABORTED PROCEDURE IS THERE WAS NO POSSIBILITY TO ACQUIRE CELLS DUE TO UNFUNCTIONAL BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.