RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2018 AS NO EVENT DATE WAS REPORTED. (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE 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 WIREGUIDED BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATORAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH MECHANISM WAS FAULTY. THE BRUSH FAILED TO EXTEND AND RETRACT. IT WAS ALSO NOTED THAT THE BRISTLED PORTION OF THE BRUSH WAS KINKED AND BENT. 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 STABLE.

Additional Manufacturer Narrative

DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2018 AS NO EVENT DATE WAS REPORTED. (B)(4). ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH (PULL WIRE AND EXTRUSION) WAS KINKED IN SEVERAL LOCATIONS, ALSO THE DISTAL END (BRUSH SECTION) WAS KINKED. MOREOVER, DURING FUNCTIONAL EVALUATION, THE DEVICE WAS NOT ABLE TO EXTEND/RETRACT WHEN THE HANDLE WAS ACTUATED, PROBABLY DUE TO THE KINKS ENCOUNTERED. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CAUSE TRACED TO COMPONENT FAILURE. 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 WIREGUIDED BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATORAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH MECHANISM WAS FAULTY. THE BRUSH FAILED TO EXTEND AND RETRACT. IT WAS ALSO NOTED THAT THE BRISTLED PORTION OF THE BRUSH WAS KINKED AND BENT. 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 STABLE.

Additional Manufacturer Narrative

DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2018 AS NO EVENT DATE WAS REPORTED. (B)(4). ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH (PULL WIRE AND EXTRUSION) WAS KINKED IN SEVERAL LOCATIONS, ALSO THE DISTAL END (BRUSH SECTION) WAS KINKED. MOREOVER, DURING FUNCTIONAL EVALUATION, THE DEVICE WAS NOT ABLE TO EXTEND/RETRACT WHEN THE HANDLE WAS ACTUATED, PROBABLY DUE TO THE KINKS ENCOUNTERED. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CAUSE TRACED TO COMPONENT FAILURE. 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 WIREGUIDED BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATORAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH MECHANISM WAS FAULTY. THE BRUSH FAILED TO EXTEND AND RETRACT. IT WAS ALSO NOTED THAT THE BRISTLED PORTION OF THE BRUSH WAS KINKED AND BENT. 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 STABLE.