BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 18477811 · Received January 9, 2024

    Report

    Report Number
    1037905-2024-00026
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 14, 2023
    Report Date
    March 7, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A RED BIOHAZARD BAG, PROVIDED WITH THE RETURN WAS AN OPEN TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. NOT ALL COMPONENTS WERE INCLUDED IN THE RETURN (ONLY 1 CATHETER WAS RETURNED). THE RETURNED CATHETER WAS STILL ATTACHED TO THE HANDLE'S NOZZLE AND HAD A NOTABLE BUILD UP OF DARK POWDER AND A REDDISH SUBSTANCE WITHIN THE DISTAL END. A KINK WAS NOTED AT THE PROXIMAL END OF THE CATHETER. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "ON" POSITION. THE RED ACTIVATION KNOB WAS DISENGAGED IN THE HANDLE INDICATING DEACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. POWDER WAS PRESENT WITHIN THE DEVICE NOZZLE. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. THE FOAM INSERT WAS PRESENT AND CORRECTLY ORIENTED INSIDE THE DEVICE. A VISUAL EXAMINATION OF THE O-RING AND LANCE INSIDE THE HANDLE SHOWED BOTH COMPONENTS TO BE POSITIONED CORRECTLY INSIDE THE HANDLE AND THE LANCE TO BE BEVELED. THE INSPECTION OF THE CO2 CARTRIDGE AND REGULATOR (LANCE AND O-RING) CONFIRM THE DEVICE WAS OF THE CURRENT DESIGN. HOWEVER, DURING INSPECTION OF THE LANCE AND O-RING IT WAS NOTED THAT THE LANCE WAS ABLE TO BE MOVED BACK AND FORTH AND PUSHED UP TOWARD THE REGULATOR, THIS IS CAUSED BY THE BACK OF THE LANCE BREAKING, MOST LIKELY DURING DEACTIVATION DUE TO THE PRESSURE BEING RELEASED BY THE CO2 CARTRIDGE. THIS DAMAGE WOULD HAVE OCCURRED AFTER THE CUSTOMER'S REPORTED DIFFICULTY WHEN DEACTIVATING THE HANDLE. DUE TO THE CONDITION OF THE RETURNED DEVICE THE LANCE COULD NOT PIERCE A NEW CO2 CARTRIDGE WITH A NEW ACTIVATION HANDLE, THE LANCE TURNED SIDEWAYS WHEN ATTEMPTING TO ACTIVATE. THE RETURNED CATHETER WAS TESTED USING A DEVICE FROM OUR SHELF STOCK. WHEN ATTEMPTING TO SPRAY, POWDER WAS OBSERVED EXITING THE NOZZLE AND MOVING THROUGH THE CATHETER UNTIL REACHING THE ACCUMULATED DARK POWDER AT THE DISTAL END OF THE CATHETER CONFIRMING THE CATHETER HAS BECOME OCCLUDED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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 AND CATHETER FOUND THE DEVICE WAS UNABLE TO SPRAY AS INTENDED. THE ROOT CAUSE FOR THE REPORT OF UNABLE TO SPRAY WAS A CLOGGED CATHETER. 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. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. CATHETER OCCLUSION/CLOGGING CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE STATE THE FOLLOWING, "PRECAUTION: TO AVOID CATHETER OCCLUSION, DO NOT PLACE CATHETER DIRECTLY IN CONTACT WITH BLOOD AND/OR MUCOSA, INCLUDING ANY POOLED BLOOD AND DO NOT ASPIRATE BLOOD WHILE CATHETER IS IN ACCESSORY CHANNEL... NOTE: IF CATHETER BECOMES OCCLUDED, TURN RED VALVE TO CLOSED POSITION, REMOVE CATHETER FROM ENDOSCOPE AND REPLACE WITH EXTRA CATHETER PROVIDED IN PACKAGE." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS 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: 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

    CONTINUED: SECTION G: 510K: K200972 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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. A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. THIS DEVICE IS WITHIN THE SCOPE OF THE CAPA. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS 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 HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT IS INCLUDED IN THE SCOPE OF THIS CORRECTIVE ACTION. 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

    IT WAS REPORTED THAT A PATIENT WITH NUMEROUS BLEEDING ULCERS IN THE ESOPHAGUS AND STOMACH HAD APC [ARGON PLASMA COAGULATION] THERAPY AND WAS STILL BLEEDING. THE PHYSICIAN THEN OPTED TO USE A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE SCOPE CHANNEL WAS FLUSHED WITH 30 CC OF AIR TWO TIMES TO ENSURE THE CHANNEL WAS DRY BEFORE INSERTING THE HEMOSPRAY CATHETER. THE DEVICE WAS ACTIVATED AND THE RED BUTTON WAS PRESSED BUT NOTHING HAPPENED [DIFFICULT OR UNABLE TO SPRAY - SUBJECT OF REPORT]. ANOTHER OF THE SAME DEVICE WAS USED WITHOUT DIFFICULTY NOR INCIDENT TO ACHIEVE HEMOSTASIS. 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
    554344 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC W4771980 00827002565722

    Patients

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