BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    MDR report key: 15824845 · Received November 18, 2022

    Report

    Report Number
    1037905-2022-00645
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 18, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: K192908. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. A PRODUCT EVALUATION WAS PERFORMED ON THE PICTURES PROVIDED WITH THIS REPORT. THE LOT NUMBER PROVIDED IN THE PHOTOS MATCHES THIS REPORT. THE LABEL IN THE PHOTO MATCHES THE PRODUCT REPORTED. THE PICTURES SHOW THE DEVICE WITH THE TIP DETACHED AND THE BRUSH REMOVED. THE COIL SPRING TIP IS STRETCHED OUT AT THE PROXIMAL END. RED DISCOLORATION IS PRESENT ON THE DETACHED TIP AND DRIVE WIRE. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE HANDLE AND THE MAJORITY OF THE CATHETER AND DRIVE WIRE WERE RETURNED AS WELL AS THE TIP OF THE DEVICE, HOWEVER THE BRUSH ITSELF WAS NOT ATTACHED TO THE DEVICE. THE DISTAL END OF THE DRIVE WIRE SHOWED EVIDENCE OF BEING CUT. THE WHITE SHEATH OVER THE PIN VISE OF THE DRIVE WIRE SHOWED BENDS/KINKS AND BROWN DISCOLORATION. THE RETURNED COIL SPRING TIP STRETCHED AT THE PROXIMAL END TO APPROXIMATELY 21 MM LONG. THE COIL SPRING TIP SHOWED RED AND BROWN DISCOLORATION AT THE PROXIMAL END. THE BRUSH WIRE IS INTACT AT THE WELD JOINT ON THE DISTAL END OF THE COIL SPRING TIP BUT IS BROKEN AT THE PROXIMAL END OF THE COIL SPRING TIP. 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: 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 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSHES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT 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 · 0

    DURING AN UNKNOWN ENDOSCOPIC PROCEDURE , THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED [THAT] THE BRUSH WAS DIFFICULT TO GET OUT IN THE PANCREATIC DUCT, BUT THE BRUSH PORTION WAS ABLE TO PASS THROUGH THE STENOSIS AND SCRAPE THROUGH. WHEN THE DEVICE WAS REMOVED FOR CELL RETRIEVAL AND PUSHED OUT THE BRUSH FROM THE SHEATH, THE PHYSICIAN FOUND THAT THE FILIFORM PART CAME OUT BROKEN. ALTHOUGH THE WIRE WAS STILL CONNECTED TO THE HAND SIDE OF THE BRUSH, IT WAS CUT AND SENT TO PATHOLOGY FOR CYTOLOGY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237691 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX WILSON-COOK MEDICAL INC G22672 W4553492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE - UNKNOWN MAKE AND MODEL