RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2020 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE 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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST BRUSH FAILED TO RETRACT INTO THE CATHETER COMPLETELY SO THEY TOOK A SECOND BRUSH AND TESTED THE DEVICE OUTSIDE OF THE PATIENT. REPORTEDLY, THE PHYSICIAN NOTED THAT THE SHAFT OF THE CATHETER WAS VERY "SLAPPY" AND BECAUSE OF THE TORTUOUS POSITION OF THE PATIENT'S BILE DUCT THERE WAS NO PUSHABILITY. WHILE INSIDE THE PATIENT, THE BRISTLED PORTION OF THE SECOND BRUSH GOT BROKEN. THE DETACHED PIECE OF THE DEVICE WAS THEN RETRIEVED USING A GRASPER. THE PROCEDURE WAS COMPLETED USING A THIRD RX CYTOLOGY BRUSH. 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 STABLE.