RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

BLOCK H2: CORRECTION: BLOCK H10 DEVICE ANALYSIS UPDATED TO REPORT LABELING REVIEW. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE INVESTIGATION RESULT OF BRUSH DETACHMENT. BLOCK H10: INVESTIGATION RESULTS THE RETURNED RX CYTOLOGY BRUSH WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DEVICE RETURNED WITHOUT THE BRUSH TIP. THE PULL WIRE WAS RETURNED KINKED AND DETACHED FROM THE HANDLE. LASTLY, THE WORKING LENGTH WAS FOUND DAMAGED (SMASHED). NO OTHER ISSUES WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. IT IS POSSIBLE THAT THE PULL WIRE WAS DETACHED FROM THE HANDLE DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED). BASED ON ALL AVAILABLE INFORMATION, ADVERSE EVENT RELATED TO PROCEDURE WAS SELECTED AS THE MOST PROBABLE CAUSE. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE WIRE CONNECTED TO THE HANDLE SUDDENLY BROKE. ANOTHER RX CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE INVESTIGATION RESULT OF BRUSH DETACHMENT. BLOCK H10: INVESTIGATION RESULTS. THE RETURNED RX CYTOLOGY BRUSH WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE DEVICE RETURNED WITHOUT THE BRUSH TIP. THE PULL WIRE WAS RETURNED KINKED AND DETACHED FROM THE HANDLE. LASTLY, THE WORKING LENGTH WAS FOUND DAMAGED (SMASHED). NO OTHER ISSUES WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. IT IS POSSIBLE THAT THE PULL WIRE WAS DETACHED FROM THE HANDLE DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED). BASED ON ALL AVAILABLE INFORMATION, ADVERSE EVENT RELATED TO PROCEDURE WAS SELECTED AS THE MOST PROBABLE CAUSE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE WIRE CONNECTED TO THE HANDLE SUDDENLY BROKE. ANOTHER RX CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF BRUSH DETACHMENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.