FUSION CYTOLOGY BRUSH

Description of Event or Problem

DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK FUSION CYTOLOGY BRUSH. IT WAS REPORTED [THAT] WHEN THE USER BRUSHED THE TUMOR TWO TIMES, THE TIP OF THE BRUSH WAS DISCONNECTED IN CHD AT THE SECOND TIME. HE TRIED TO USE [COOK PRODUCTS] MB5-2X4-8 AND FS-QEB-B BUT COULDN'T TAKE IT [DETACHED BRUSH TIP] OUT AND TIP RUN TO IHD. FINALLY, HE PLACED AN OACL PLASTIC STENT. A SECTION OF THE DETACHED CYTOLOGY BRUSH TIP REMAINED INSIDE THE PATIENT¿S BODY. A PLASTIC STENT WAS PLACED.

Additional Manufacturer Narrative

SECTION H: PMA/510(K):K192908 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT WAS CONFIRMED WITH THE PICTURES PROVIDED. THE PHOTOS WERE X-RAY IMAGES WHICH SHOWED THE DEVICE DURING USE, BEFORE AND AFTER THE BRUSH TIP DETACHED INSIDE OF THE PATIENT. 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 PHOTOS PROVIDED AND STATEMENTS DESCRIBING THE EVENT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL FUSION CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE POSSIBLE DEVICE HISTORY RECORDS CONFIRMED THAT THE LOTS SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG. A LOT NUMBER WAS NOT PROVIDED WITH THE RETURN. PICTURES WERE PROVIDED AND REVIEWED. THE PHOTOS WERE X-RAY IMAGES WHICH SHOWED THE DEVICE DURING USE, BEFORE AND AFTER THE BRUSH TIP DETACHED INSIDE OF THE PATIENT. A PICTURE OF THE LOT NUMBER WAS NOT PROVIDED. AN ADDITIONAL PICTURE WAS PROVIDED AND REVIEWED. THE PICTURE SHOWS THE DETACHED BRUSH TIP/COIL SPRING IN A CLEAR BAG, CONFIRMING THE COMPLAINT. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE. ONLY THE DETACHED COIL SPRING OF THE DEVICE WAS RETURNED; THE BRUSH, DRIVE WIRE, AND HANDLE WERE NOT INCLUDED AND THEREFORE A FULL EVALUATION WAS NOT POSSIBLE. THE RETURNED TIP IS APPROXIMATELY 17 MM TOTAL IN LENGTH WITH APPROXIMATELY 4 MM THAT IS STRETCHED OUT AND APPEARS TO HAVE BROKEN AFTER THE BRUSH WIRE TO TIP SOLDER JOINT. THE WELD BALL IS PRESENT ON THE DISTAL END OF THE TIP AND AN UNKNOWN REDDISH SUBSTANCE WAS OBSERVED ON THE PROXIMAL PORTION OF THE COIL SPRING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE PICTURES PROVIDED AND RETURNED DEVICE PORTION CONFIRMED THE REPORT. HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. WITHOUT THE BRUSH AT THE DISTAL END OF THE DEVICE, THE JOINT BETWEEN THE BRUSH AND THE COIL SPRING TIP COULD NOT BE FULLY EVALUATED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. PRIOR TO DISTRIBUTION, ALL FUSION CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE POSSIBLE DEVICE HISTORY RECORDS CONFIRMED THAT THE LOTS SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

Description of Event or Problem

DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK FUSION CYTOLOGY BRUSH. IT WAS REPORTED [THAT] WHEN THE USER BRUSHED THE TUMOR TWO TIMES, THE TIP OF THE BRUSH WAS DISCONNECTED IN CHD AT THE SECOND TIME. HE TRIED TO USE [COOK PRODUCTS] MB5-2X4-8 AND FS-QEB-B BUT COULDN'T TAKE IT [DETACHED BRUSH TIP] OUT AND TIP RUN TO IHD. FINALLY, HE PLACED AN OACL PLASTIC STENT. THE CUSTOMER PROVIDED A PHOTO SHOWING BRUSH TIP BEFORE AND AFTER DETACHMENT, INCLUDING A RADIOGRAPH REVEALING THE DETACHED BRUSH TIP IN PATIENT. A SECTION OF THE DETACHED CYTOLOGY BRUSH TIP REMAINED INSIDE THE PATIENT¿S BODY. A PLASTIC STENT WAS PLACED. THE PATIENT UNDERWENT TWO ADDITIONAL PROCEDURES [PERCUTANEOUS TRANSHEPATIC CHOLANGIAL DRAINAGE] TO TAKE OUT REMAINING BODY PRODUCTS BY EARLY (B)(6) 2024. THE DETACHED DEFECTIVE PRODUCT WAS SUCCESSFULLY REMOVED FROM PATIENT ON (B)(6) 2024.