RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

(B)(4). INVESTIGATION RESULTS: THE RETURNED RX CYTOLOGY BRUSH WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DEVICE RETURNED WITHOUT THE BRUSH. THE PULL WIRE WAS KINKED, THE WORKING LENGTH SHOWED REMNANTS OF USE, AND THE INTERNAL PULL WIRE WAS RETURNED OUTSIDE OF THE WORKING LENGTH. IN ADDITION, THE HANDLE WAS BENT. THE HANDLE WAS DISASSEMBLED AND THE PULL WIRE WAS DETACHED FROM THE HANDLE. NO OTHER PROBLEMS WERE NOTED. THE REPORTED COMPLAINT OF BRUSH BENT CANNOT BE CONFIRMED SINCE THE BRUSH WAS NOT RETURNED. IT WAS NOT POSSIBLE TO CARRY OUT A MORE THOROUGH INVESTIGATION TO DETERMINE THE INFLUENCE OF THIS PART IN THE EVENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE PROBLEM REPORTED IS "NO PROBLEM DETECTED". THE PRODUCT RECORD REVIEW CONFIRMED THAT THIS IS NOT A NEW FAILURE TYPE AND THE RISK IS ANTICIPATED. THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE, DESIGN OR USER ISSUE WHICH COULD HAVE CAUSED THE COMPLAINT. IT WAS POSSIBLE THAT DUE TO THE MANIPULATION OR THE TECHNIQUE USED AT THE TIME TO INTERACT WITH THE DEVICE, IN CONJUNCTION WITH THE PATIENT'S TORTUOSITY OR ANATOMICAL CONDITIONS COULD HAVE AFFECTED THE FUNCTIONALITY OF THE DEVICE, (IT WAS REPORTED THAT THE DEVICE WAS USED IN A TORTUOUS POSITION); THEN, AN EXCESS FORCE COULD HAVE BEEN APPLIED, BENDING THE HANDLE AND THE INTERNAL PULL WIRE, AND CAUSING THE DETACHMENT. BASED ON THE INFORMATION AVAILABLE AND THE RETURNED DEVICE ANALYSIS, THE MOST PROBABLE ROOT CAUSE FOR THE PROBLEMS FOUND DURING ANALYSIS 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 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 BILIARY DURING A BILIARY TISSUE SAMPLING PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE BRISTLED PORTION OF THE BRUSH WAS BENT. THE DEVICE WAS IN A TORTUOUS POSITION WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BRUSH DETACHMENT.