RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF 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 BILIARY RX CYTOLOGY BRUSH WIREGUIDED WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH TIP WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BILIARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

Additional Manufacturer Narrative

PROBLEM CODE 2981 CAPTURES THE REPORTABLE EVENT OF BRUSH BENT. AN RX CYTOLOGY BRUSH WAS RETURNED FOR EVALUATION. A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE BRUSH WAS EXTENDED WHEN RECEIVED. THE EXTRUSION WAS FREE OF OBVIOUS KINKS AND BENDS. IN ADDITION, THE DISTAL SECTION OF THE BRUSH WAS SLIGHTLY KINKED. 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 KINK THE BRUSH AT DISTAL END. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE 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 BILIARY RX CYTOLOGY BRUSH WIREGUIDED WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018 . ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH TIP WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BILIARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.