RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

BLOCK H6: DEVICE CODE A0501 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF BRUSH DETACHMENT OF DEVICE OR DEVICE COMPONENT. IMDRF CODE F2301 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX CYTOLOGY BRUSH WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN ATTEMPTING TO BRUSH, THE TIP OF THE PLASTIC BRUSH BROKE OFF AND ENTERED THE COMMON BILE DUCT, ATTEMPTS TO RETRIEVE THE DETACHED FRAGMENT USING A SNARE WERE PERFORMED BUT IT WAS NOT POSSIBLE TO RETRIEVE THE FOREIGN BODY THAT BECAME LOST IN THE BILE DUCT. THE PROCEDURE WAS COMPLETED WITH PLACEMENT OF A COVERED METAL STENT (40 X 10 MM), WITH GOOD BILIARY DRAINAGE. A FOLLOW-UP CT SCAN WAS PERFORMED DUE TO POSSIBLE COMPLICATION RELATED TO THE TYPE OF PROCEDURE, RATHER THAN THE FOREIGN BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE NO CLINICAL CONSEQUENCES UPON DISCHARGE FROM THE OPERATING ROOM AND NO POST-OPERATIVE CLINICAL CONSEQUENCES RELATED TO THIS FOREIGN BODY.