RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

THE EXACT AGE OF THE PATIENT IS UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS. (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 BRUSH WIREGUIDED WAS TO BE USED IN THE BILE DUCT TO DIAGNOSE A SUSPECTED CHOLANGIOCARCINOMA DURING A SCRAPING CYTOLOGY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE BILE DUCT ALONG THE GUIDEWIRE. BRUSHING WAS PERFORMED SEVERAL TIMES AND WHEN TRYING TO RETRACT THE BRUSH INTO THE CATHETER, THE WIRE INSIDE THE CATHETER NEAR THE INJECTION PORT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIREGUIDED WAS TO BE USED IN THE BILE DUCT TO DIAGNOSE A SUSPECTED CHOLANGIOCARCINOMA DURING A SCRAPING CYTOLOGY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE BILE DUCT ALONG THE GUIDEWIRE. BRUSHING WAS PERFORMED SEVERAL TIMES AND WHEN TRYING TO RETRACT THE BRUSH INTO THE CATHETER, THE WIRE INSIDE THE CATHETER NEAR THE INJECTION PORT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

Additional Manufacturer Narrative

THE EXACT AGE OF THE PATIENT IS UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS. (B)(4). AN RX CYTOLOGY BRUSH WAS RECEIVED FOR EVALUATION. A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE HANDLE WAS DETACHED. THE PULL WIRE WAS ALSO KINKED AND BROKEN AT ITS PROXIMAL SECTION (DISTAL END OF THE HANDLE CANNULA) WHICH CAUSED THE SEPARATION OF THE HANDLE FROM THE REST OF THE DEVICE. NO OTHER ANOMALIES WERE NOTED. THE FAILURES FOUND OF PULL WIRE KINKED AND BROKEN NOTED WITH THE RETURNED DEVICE COULD HAVE BEEN GENERATED BY EXCESSIVE MANIPULATION OF THE DEVICE BY THE USER AND/OR EXCESS OF FORCE APPLIED TO THE PRODUCT; ONCE THIS SECTION OF THE UNIT HAS BEEN DAMAGED IT CAN AFFECT THE FUNCTIONALITY OF THE PRODUCT. IN ADDITION, IT IS VERY IMPORTANT TO TAKE INTO CONSIDERATION THAT THE EVENT DESCRIPTION STATED THAT BRUSHING WAS PERFORMED SEVERAL TIMES AND WHEN TRYING TO RETRACT THE BRUSH INTO THE CATHETER, THE INNER GOT SEPARATED, WHICH IS EVIDENCE THAT THE UNIT COULD HAVE BEEN DAMAGED DURING ITS USE. 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 THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.