FUSION CYTOLOGY BRUSH

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURE PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. OUR EVALUATION OF THE PICTURE PROVIDED CONFIRMED THE REPORT. THE PICTURE IS AN X-RAY IMAGE SHOWING THE DETACHED BRUSH TIP/COIL SPRING INSIDE THE PATIENT, CONFIRMING THE COMPLAINT. A PICTURE OF THE LOT NUMBER WAS NOT PROVIDED. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON THE PHOTO PROVIDED AND STATEMENTS DESCRIBING THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE PICTURE PROVIDED CONFIRMED THE REPORT. A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO REDUCE OCCURRENCES OF BRUSH TIP/COIL SPRING DETACHMENT FOR CYTOLOGY BRUSH DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. PRIOR TO DISTRIBUTION, ALL FUSION CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BRUSH TIP/COIL SPRING DETACHMENT. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

Description of Event or Problem

DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK FUSION CYTOLOGY BRUSH. IT WAS REPORTED [THAT] AFTER TEN ATTEMPTS WITH BRUSH AND AFTER X-RAY IMAGING, THE [USER] NOTICED THAT THE DEVICE'S SPRING COIL TIP WAS MISSING [DETACHED]. A COMPETITOR EXTRACTION BALLOON WAS USED TO PULL DETACHED SPRING COIL TIP INTO DUODENUM AND IT REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.