BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    MDR report key: 19408644 · Received May 28, 2024

    Report

    Report Number
    1037905-2024-00299
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 3, 2024
    Report Date
    June 21, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FDX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G: PMA/510(K): K192908. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BIOHAZARD BAG. PROVIDED WITH THE RETURN WAS TWO OPEN POUCHES FROM THE POSSIBLE LOT NUMBERS PROVIDED IN THE REPORT. THE LABELS MATCH THE PRODUCT RETURNED. SEVEN ADDITIONAL SEALED DEVICES FROM THREE DIFFERENT LOT NUMBERS WERE ALSO INCLUDED IN THE RETURN. PICTURES WERE ALSO PROVIDED AND REVIEWED. TWO PICTURES SHOW THE LABEL ON THE POUCHES OF THE POSSIBLE LOT NUMBERS. THE THIRD PICTURE IS A FLURO X-RAY IMAGE WHICH SHOWED THE DEVICE DURING USE WITH THE TIP DETACHED INSIDE THE PATIENT. THE FOURTH PICTURE SHOWS THE TIP AFTER IT WAS RETRIEVED. USED DEVICE: OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED AND PICTURES PROVIDED CONFIRMED THE COMPLAINT. THE DEVICE WAS RETURNED WITHOUT MOST OF THE BRUSH AND WITHOUT THE DETACHED COIL SPRING. IT IS PRESUMED THE PORTION OF THE BRUSH THAT WAS NOT RETURNED WAS USED FOR PATHOLOGY AND WAS NOT RETURNED. THE CATHETER AND DRIVE WIRE TO HANDLE CANNULA ASSEMBLY WAS INCLUDED IN THE RETURN. THE END OF THE DRIVE WIRE SHOWS EVIDENCE OF BEING CUT. DUE TO THE CONDITION OF THE RETURNED DEVICE A FULL EVALUATION WAS NOT POSSIBLE AND WE WERE UNABLE TO DETERMINE A CAUSE FOR THE COIL SPRING DETACHING FROM THE BRUSH. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE WAS NOT OBSERVED. SEALED DEVICES FROM LOT W4810603 ((B)(6) ) AND W4812108 (QTY (B)(6) ): OUR EVALUATION OF THE RETURNED SEALED DEVICES COULD NOT CONFIRM THE REPORT OF COIL SPRING DETACHES. THE SAMPLES WERE SUBMITTED TO THE ENGINEERING TEST LAB (ETL) TO TENSILE TEST THE COIL SPRING TO BRUSH WIRE JOINT. EACH OF THE COIL SPRINGS SEPARATED FROM THE BRUSH WIRE WITHIN THE ACCEPTANCE CRITERIA. SEALED DEVICE FROM LOT W4787734: OUR EVALUATION OF THE RETURNED SEALED DEVICE CONFIRMED THE REPORT OF COIL SPRING DETACHES. THE SAMPLE WAS SUBMITTED TO THE ENGINEERING TEST LAB (ETL) TO TENSILE TEST THE COIL SPRING TO BRUSH WIRE JOINT. THE COIL SPRING SEPARATED FROM THE BRUSH WIRE BELOW ACCEPTANCE CRITERIA. A LAB MEETING WAS HELD WITH PRODUCTION MANAGEMENT AND PRODUCTION ENGINEERING ON 22 MAY 2024. THE SEALED DEVICE FROM LOT W4787734 WAS EXAMINED AND COMPARED THE OTHER SEALED DEVICES THAT PASSED THE TENSILE TEST. DURING THE LAB MEETING IT WAS DETERMINED THAT THE DEVICE FROM LOT W4787734 LIKELY FAILED DUE TO OVER BUFFING AFTER THE SOLDERING PROCESS. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. FOR ADDITIONAL TESTING, TWO WAREHOUSE PRODUCT PULLS WERE PERFORMED FOR THE SAME OPERATOR AS THE SEALED DEVICE FROM LOT W4787734 THAT FAILED TO MEET THE ACCEPTANCE CRITERIA, AND REMAINING OPERATORS. ONE DEVICE DID NOT MEET ACCEPTANCE CRITERIA. THE DEVICE HISTORY RECORDS FOR THE POSSIBLE LOT NUMBERS SAID TO BE INVOLVED AND THE ADDITIONAL SEALED DEVICES RETURNED WERE REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: USED DEVICE: OUR EVALUATION OF THE PICTURES PROVIDED AND RETURNED DEVICE 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 AND THE DETACHED COIL SPRING, 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. RETURNED SEALED DEVICES FROM LOT W4810603 ((B)(6) ) AND W4812108 ((B)(6) ): OUR EVALUATION OF THE RETURNED SEALED DEVICES COULD NOT CONFIRM THE REPORT. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. RETURNED SEALED DEVICE FROM LOT W4787734: OUR EVALUATION OF THE RETURNED SEALED DEVICE CONFIRMED THE REPORT. THE COIL SPRING TO BRUSH WIRE JOINT FAILED TENSILE TESTING AND IT WAS DETERMINED THAT IT LIKELY FAILED DUE TO OVER BUFFING DURING THE MANUFACTURING PROCESS. THIS NONCONFORMANCE OCCURRED DUE TO OPERATOR ERROR. PRODUCTION MANAGEMENT AND THE DEPARTMENT TEAM LEADS WERE NOTIFIED OF THIS OCCURRENCE (REFERENCE (B)(4). ADDITIONALLY, A NOTIFICATION OF OPERATOR RELATED COMPLAINT FORM WAS PROVIDED TO PRODUCTION MANAGEMENT (REFERENCE NOTIFICATION OF OPERATOR RELATED COMPLAINT (B)(4). THE RELATED OPERATOR HAS BEEN DISQUALIFIED FROM COMPLETING THIS MANUFACTURING PROCESS AS A RESULT OF THIS COMPLAINT. WAREHOUSE-PULLED DEVICES FROM LOT W4828808 ((B)(6) ), W4834170 ((B)(6) ), W4830489 ((B)(6) ), W4834623 ((B)(6) ), W4834623 ((B)(6) ), W4833075 ((B)(6) ), DEVICES 2-10 FROM W4827189, AND THE REMAINING DEVICES FROM LOT W4827189 ((B)(6) ): OUR EVALUATION OF THE SEALED DEVICES COULD NOT CONFIRM THE REPORT. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. WAREHOUSE-PULLED DEVICE #1 FROM LOT W4827189: OUR EVALUATION OF THE RETURNED SEALED DEVICE CONFIRMED THE REPORT. THE COIL SPRING TO BRUSH WIRE JOINT FAILED TENSILE TESTING AND IT WAS DETERMINED THAT IT LIKELY FAILED DUE TO OVER BUFFING DURING THE MANUFACTURING PROCESS. 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 RECORDS 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.

    Additional Manufacturer Narrative · 0

    SECTION G: PMA/510(K): K192908. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. IT WAS REPORTED [THAT THE] BRUSH BROKE INSIDE OF A PATIENT. HE [PHYSICIAN] WAS ABLE TO RETRIEVE IT. IMAGES PROVIDED OF DETACHED CYTOLOGY BRUSH PORTION. THE DETACHED DEVICE PORTION DID NOT REMAIN INSIDE THE PATIENT. AN ADDITIONAL PROCEDURE WAS REQUIRED TO RETRIEVED DETACHED DEVICE POTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332001 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN ENDOSCOPE