BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    MDR report key: 21138229 · Received January 13, 2025

    Report

    Report Number
    1037905-2025-00042
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 6, 2024
    Report Date
    February 20, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDX
    UDI-DI
    10827002226743
    PMA / PMN Number
    K192908
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION G: 510K: K192908. POSTAL CODE (B)(6). PHONE (B)(6). INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE. ONLY THE CATHETER AND DRIVE WIRE TO BRUSH ASSEMBLY WAS INCLUDED IN THE RETURN. A VISUAL EXAMINATION OF THE DEVICE DID NOT SHOW ANY KINKS; HOWEVER, THE BRUSH TIP/COIL SPRING HAS DETACHED FROM THE BRUSH WIRE AND WAS NOT INCLUDED. DURING A CLOSE VISUAL EXAMINATION OF THE DEVICE SOLDER WAS OBSERVED AT THE DISTAL END OF THE DRIVE WIRE. AN UNKNOWN REDDISH AND DARK SUBSTANCE WAS OBSERVED ON THE PROXIMAL/HANDLE PORTION OF THE DEVICE AND WITHIN THE BRUSH LUMEN OF THE CATHETER. 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 RETURNED DEVICE 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 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 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.

    Additional Manufacturer Narrative · 0

    CONTINUED: PHONE (B)(6). INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT BASED ON THE CONDITION OF THE RETURNED DEVICE. ONLY THE CATHETER AND DRIVE WIRE TO BRUSH ASSEMBLY WAS INCLUDED IN THE RETURN. A VISUAL EXAMINATION OF THE DEVICE DID NOT SHOW ANY KINKS; HOWEVER, THE BRUSH TIP/COIL SPRING HAS DETACHED FROM THE BRUSH WIRE AND WAS NOT INCLUDED. DURING A CLOSE VISUAL EXAMINATION OF THE DEVICE SOLDER WAS OBSERVED AT THE DISTAL END OF THE DRIVE WIRE. AN UNKNOWN REDDISH AND DARK SUBSTANCE WAS OBSERVED ON THE PROXIMAL/HANDLE PORTION OF THE DEVICE AND WITHIN THE BRUSH LUMEN OF THE CATHETER. 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 RETURNED DEVICE 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 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 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 · 0

    DURING A BILE DUCT BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED THAT A KINK WAS NOTICED DURING THE PROCEDURE, BUT IT WAS PERFORMED TO THE END. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON 1(B)(6)2024 AND THE COIL SPRING IS DETACHED AND MISSING. IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER, THE LOCATION OF THE MISSING PORTION IS UNKNOWN. 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.

    Description of Event or Problem · 0

    DURING A BILE DUCT BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED THAT A KINK WAS NOTICED DURING THE PROCEDURE, BUT IT WAS PERFORMED TO THE END. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON (B)(6) 2024 AND THE COIL SPRING IS DETACHED AND MISSING. IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER, THE LOCATION OF THE MISSING PORTION IS UNKNOWN. 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. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE USER FOUND THE TIP WAS DETACHED AND MISSING AFTER SEVERAL BRUSHING. HE DID NOT FIND THE TIP IN THE PATIENT BODY UNDER DIRECT OR FLUOROSCOPIC VISION. HE DETERMINED THE TIP WILL BE EXCRETED NATURALLY AND COMPLETED THE PROCEDURE WITHOUT FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517563 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX WILSON-COOK MEDICAL INC G22674 W4821323 10827002226743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENDOSCOPE-UNKNOWN MAKE OR MODEL.