RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

INITIAL REPORTER ADDRESS: (B)(6). : DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BRUSH DETACHMENT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THERE WERE KINKED MARKS ON THE SHAFT AND THE BRUSH TIP HAD DETACHED. ANOTHER RX CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING PROCEDURE WAS REPORTED TO BE STABLE.

Additional Manufacturer Narrative

BLOCK E1: INITIAL REPORTER ADDRESS: (B)(6). BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BRUSH DETACHMENT. BLOCK H11: THE RETURNED RX CYTOLOGY BRUSH WAS ANALYZED, AND A PRODUCT ANALYSIS OBSERVED SEVERAL KINKS THROUGHOUT THE WORKING LENGTH. THE BRUSH WAS FOUND NOT DETACHED; HOWEVER, IT WAS NOT ABLE TO EXTEND SINCE THE WIRE FROM THE WORKING LENGTH IS DETACHED FROM THE CANNULA. THE REPORTED BRUSH DETACHMENT WAS NOT CONFIRMED. THE COMPLAINT INFORMATION REPORTS THAT THE DEVICE WAS DAMAGED PRIOR TO PROCEDURE; HOWEVER, IT RETURNED WITH DAMAGES THAT SUGGEST THAT THE DEVICE WAS USED DURING A PROCEDURE. BASED ON ALL AVAILABLE INFORMATION, IT IS MOST LIKELY DUE TO THE PHYSICIAN'S TECHNIQUE AT THE TIME OF EXTENDING AND RETRACTING THE BRUSH WHICH DUE TO FRICTION AND POSSIBLE TORTUOSITY OF THE PROCEDURE COULD HAVE CAUSED THE DETACHMENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE INVESTIGATION FINDINGS HANDLE DETACHED/SEPARATED AND WORKING LENGTH BENT/KINKED IS ADVERSE EVENT RELATED TO PROCEDURE. THE BRUSH WAS NOT DETACHED AS REPORTED; HOWEVER, IT WASN'T ABLE TO BE EXTENDED FROM THE WORKING LENGTH SINCE THE WIRE FROM THE HANDLE CANNULA WAS DETACHED. THEREFORE, THE REPORTED EVENT OF BRUSH DETACHMENT WAS ADDRESSED AS NO PROBLEM DETECTED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THERE WERE KINKED MARKS ON THE SHAFT AND THE BRUSH TIP HAD DETACHED. ANOTHER RX CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING PROCEDURE WAS REPORTED TO BE STABLE.