RX CYTOLOGY BRUSH

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIRE GUIDED WAS USED IN THE 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 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS BROKEN WHEN IT WAS RETRACTED INTO THE CATHETER THROUGH THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE OKAY.

Additional Manufacturer Narrative

(B)(4). INVESTIGATION RESULTS: FUNCTIONAL EVALUATION OF THE DEVICE REVEALED THAT THE BRUSH WAS UNABLE TO EXTEND AND RETRACT NORMALLY WHEN THE HANDLE WAS ACTUATED. THE DEVICE WAS DISASSEMBLED (BLUE CAP WAS UNSCREWED) AND IT WAS OBSERVED THAT THE PULL WIRE WAS SLIGHTLY KINKED AND BROKEN AT THE PROXIMAL END (DISTAL END OF THE HANDLE CANNULA). LIKELY THE FAILURES FOUND (PULL WIRE KINK/BROKEN) WAS CAUSED DUE TO MANIPULATION AS THE CUSTOMER BRUSHED BACK AND FORTH DURING UNPACKING, PREPPING OR TESTING. HANDLING AND MANIPULATION OF THE DEVICE CAN LEAD TO BEND THE CATHETER AND PULL WIRE, THIS CONDITION CAN CAUSE DIFFICULTIES TO EXTEND/RETRACT THE BRUSH, FORCE APPLIED TO THE HANDLE IN ORDER TO EXTEND/RETRACT THE BRUSH CAN RESULT IN KINKING THE PULL WIRE AT HANDLE CANNULA JOINT, CONTINUED MOVEMENTS OF THE HANDLE CAN RESULT IN PULL WIRE BREAKAGE. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

Additional Manufacturer Narrative

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 WIREGUIDED WAS USED IN THE 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 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS BROKEN WHEN IT WAS RETRACTED INTO THE CATHETER THROUGH THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE OKAY.