RX CYTOLOGY BRUSH

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIREGUIDED WAS USED TO DIAGNOSE A CHOLANGIOCARCINOMA IN THE BILE DUCT DURING A SCRAPING CYTOLOGY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN STARTING TO SCRAPE FOR TISSUE SAMPLE, SEVERE RESISTANCE WAS FELT, SO THE DEVICE WAS REMOVED. UPON CHECKING, THE TIP WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK E1:INITIAL REPORTER ADDRESS (B)(6). BLOCK H6: (B)(4). BLOCK H10: INVESTIGATION RESULTS: AN RX CYTOLOGY BRUSH WAS RETURNED FOR ANALYSIS. A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE BRUSH WAS RETRACTED WHEN RECEIVED. ANALYSIS OF THE RETURNED DEVICE ALSO REVEALED THAT THE WORKING LENGTH WAS FREE OF OBVIOUS KINKS AND BENDS. THE DISTAL SECTION OF THE DEVICE (BRUSH SECTION) WAS KINKED. DURING FUNCTIONAL ANALYSIS, THE BRUSH COULD BE EXTENDED AND RETRACTED WITHOUT ANY ISSUES. THE BRUSH EXTENSION/RETRACTION WERE MEASURED AND BOTH DIMENSIONS WERE FOUND WITHIN MANUFACTURING SPECIFICATIONS, THEREFORE THE REPORTED ISSUE OF "BRUSH DIFFICULT TO EXTEND" WAS NOT CONFIRMED. AS PER COMPLAINT INFORMATION, THE ISSUE OCCURRED DURING THE PROCEDURE. IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE USE OF THE DEVICE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. HANDLING AND MANIPULATION OF THE DEVICE DURING ITS USE CAN LEAD TO KINKING OF THE DISTAL SECTION (BRUSH SECTION). BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ADVERSE EVENT RELATED TO PROCEDURE SINCE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT. 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

(B)(6). (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 USED TO DIAGNOSE A CHOLANGIOCARCINOMA IN THE BILE DUCT DURING A SCRAPING CYTOLOGY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN STARTING TO SCRAPE FOR TISSUE SAMPLE, SEVERE RESISTANCE WAS FELT, SO THE DEVICE WAS REMOVED. UPON CHECKING, THE TIP WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.