RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

PROBLEM CODE 2981 CAPTURES THE REPORTABLE EVENT OF BRUSH BENT. A RX CYTOLOGY BRUSH WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH (EXTRUSION AND PULL WIRE) WAS KINKED IN SEVERAL LOCATIONS. THE BRUSH WAS RECEIVED EXTENDED. THE DISTAL SECTION OF THE DEVICE (BRUSH SECTION) WAS SEVERELY KINKED. A FUNCTIONAL EVALUATION WAS ALSO PERFORMED AND THE BRUSH FAILED TO RETRACT DUE TO THE KINKS FOUND ON THE WORKING LENGTH. THE KINK ON THE BRUSH SECTION ALSO IMPEDED A PROPER RETRACTION OF THE BRUSH. IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. HANDLING AND MANIPULATION OF THE DEVICE DURING ITS USE CAN LEAD TO KINKING OF THE DEVICE IN SEVERAL LOCATIONS, INCLUDING THE DISTAL SECTION. 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.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX CYTOLOGY BRUSH WIREGUIDED WAS USED IN THE BILE DUCT DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS RETRACTED DURING SCRAPING CYTOLOGY, IT SEEMED THAT THE BRISTLED PORTION OF THE BRUSH WAS BENT AND IT WAS UNABLE TO BE RETRACTED. THE DEVICE WAS REMOVED WITHOUT BEING RETRACTED AND THE PROCEDURE WAS COMPLETED USING ANOTHER CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

PROBLEM CODE CAPTURES THE REPORTABLE EVENT OF BRUSH BENT.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 A RX CYTOLOGY BRUSH WIREGUIDED WAS USED IN THE BILE DUCT DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS RETRACTED DURING SCRAPING CYTOLOGY, IT SEEMED THAT THE BRISTLED PORTION OF THE BRUSH WAS BENT AND IT WAS UNABLE TO BE RETRACTED. THE DEVICE WAS REMOVED WITHOUT BEING RETRACTED AND THE PROCEDURE WAS COMPLETED USING ANOTHER CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.