RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

BLOCK E1: HEALTHCARE FACILITY: (B)(6) UNIVERSITY. BLOCK H6: IMDFR DEVICE CODE A0501 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF BRUSH DETACHED. BLOCK H10: INVESTIGATION RESULTS THE RETURNED RX CYTOLOGY BRUSH WAS ANALYZED, AND IT SHOWED THAT THE BRUSH WAS DETACHED AND DID NOT RETURN FOR INVESTIGATION. IN ADDITION, THE HANDLE WAS MOVED HOWEVER NO MOVEMENT OF THE WIRE WAS NOTED. THIS IS POSSIBLY DUE TO THE WIRE BEING DETACHED FROM THE HANDLE, WHICH WAS CONFIRMED THROUGH X-RAY. THE REPORTED EVENT WAS CONFIRMED. ADDITIONALLY, THE WIRE WAS DETACHED FROM THE HANDLE AND THE BRUSH WAS DETACHED. MOST LIKELY, THE REPORTED EVENT AND ADDITIONAL INVESTIGATION FINDINGS COULD HAVE BEEN DUE TO EXCESSIVE FORCE APPLIED WHEN EXTENDING/RETRACTING THE BRUSH THAT GOT THE WIRE KINKED, AND LATER DETACHED. THE BRUSH DID NOT RETURN FOR INVESTIGATION AND THE REASON FOR THE BRUSH DETACHMENT REMAINS UNKNOWN. BASED ON ALL AVAILABLE INFORMATION, ADVERSE EVENT RELATED TO PROCEDURE WAS SELECTED AS THE MOST PROBABLE ROOT CAUSE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE BRUSH COULD NOT EXTEND OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF THE BRUSH DETACHED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

Additional Manufacturer Narrative

BLOCK E1: HEALTHCARE FACILITY: (B)(6). BLOCK H6: IMDFR DEVICE CODE A0501 CAPTURES THE REPORTABLE INVESTIGATION FINDING OF BRUSH DETACHED. BLOCK H11: INVESTIGATION RESULTS: THE RETURNED RX CYTOLOGY BRUSH WAS ANALYZED, AND IT SHOWED THAT THE BRUSH WAS DETACHED AND DID NOT RETURN FOR INVESTIGATION. IN ADDITION, THE HANDLE WAS MOVED HOWEVER NO MOVEMENT OF THE WIRE WAS NOTED. THIS IS POSSIBLY DUE TO THE WIRE BEING DETACHED FROM THE HANDLE, WHICH WAS CONFIRMED THROUGH X-RAY. THE REPORTED EVENT WAS CONFIRMED. ADDITIONALLY, THE WIRE WAS DETACHED FROM THE HANDLE AND THE BRUSH WAS DETACHED. MOST LIKELY, THE REPORTED EVENT AND ADDITIONAL INVESTIGATION FINDINGS COULD HAVE BEEN DUE TO EXCESSIVE FORCE APPLIED WHEN EXTENDING/RETRACTING THE BRUSH THAT GOT THE WIRE KINKED, AND LATER DETACHED. THE BRUSH DID NOT RETURN FOR INVESTIGATION AND THE REASON FOR THE BRUSH DETACHMENT REMAINS UNKNOWN. BASED ON ALL AVAILABLE INFORMATION, ADVERSE EVENT RELATED TO PROCEDURE WAS SELECTED AS THE MOST PROBABLE ROOT CAUSE. BLOCK H11: BLOCK A1 HAS BEEN CORRECTED FROM (B)(6). BLOCK A2, PATIENT AGE, HAS BEEN CORRECTED FROM 70 TO 47. BLOCK B5 HAS BEEN UPDATED. BLOCK G2 HAS BEEN UPDATED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024, FOR THE TREATMENT OF TUMOR OF PANCREAS. DURING THE PROCEDURE, THE BRUSH COULD NOT EXTEND OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF THE BRUSH DETACHED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.