RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE CORRECT LOT NUMBER OF THE SUSPECT DEVICE. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE BRUSHING THE BILE DUCT, BRISTLES OF THE BRUSH DETACHED AND FELL INSIDE THE PATIENT. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUROUS AND THE SCOPE NOT PLACED IN A TORTUROUS PATH. THE DOCTOR ATTEMPTED TO REMOVE THE DETACHED BRISTLES FROM INSIDE THE PATIENT USING ASPIRATION AND SNARING. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE BRUSHING THE BILE DUCT, BRISTLES OF THE BRUSH DETACHED AND FELL INSIDE THE PATIENT. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUROUS AND THE SCOPE NOT PLACED IN A TORTUROUS PATH. THE DOCTOR ATTEMPTED TO REMOVE THE DETACHED BRISTLES FROM INSIDE THE PATIENT USING ASPIRATION AND SNARING. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. ***ADDITIONAL INFORMATION NOTED ON (B)(6) 2019*** UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS NOTED THAT THE CORRECT PROCEDURE DATE IS (B)(6), 2019.

Additional Manufacturer Narrative

H10: BLOCKS B3 AND B5 HAVE BEEN UPDATED. BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE CORRECT LOT NUMBER OF THE SUSPECT DEVICE. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. BLOCK H6: PROBLEM CODE 1562 CAPTURES THE REPORTABLE EVENT OF BRUSH MATERIAL SEPARATION. CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.