BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 9349283 · Received November 20, 2019

    Report

    Report Number
    1037905-2019-00710
    Event Type
    Death
    Date Received
    November 20, 2019
    Date of Event
    October 27, 2019
    Report Date
    October 29, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002565722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE: COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. INFORMATION REGARDING OTHER INFORMATION: DEN170015. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ALL COMPONENTS WERE NOT INCLUDED IN THE RETURN (NO CATHETERS WERE RETURNED), THEREFORE A COMPLETE EVALUATION WAS NOT POSSIBLE. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. BLOOD WAS PRESENT ON THE EXTERIOR OF THE DEVICE. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE CO2 CARTRIDGE DID NOT DISCHARGE UPON DEACTIVATION OF THE DEVICE AND THE CO2 CARTRIDGE WAS MISSING FROM THE DEVICE. THE LANCE POSITION WAS MEASURED AND FOUND TO BE POSITIONED CORRECTLY. 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 REGULATOR (LANCE AND O-RING) CONFIRM THE DEVICE WAS OF THE CURRENT DESIGN. A FUNCTIONAL TEST WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB WAS ATTEMPTED, HOWEVER THE LANCE INSIDE THE REGULATOR ROTATED AT THIS TIME AND NO FURTHER FUNCTIONAL TESTING COULD BE CONDUCTED. THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF POWDER. NO CLUMPS OF POWDER OR OBSTRUCTIONS WERE FOUND IN THE TUBE BETWEEN THE POWDER CHAMBER AND ON/OFF VALVE OR IN THE TUBE BETWEEN THE POWDER CHAMBER AND THE REGULATOR. VISUAL AND PHYSICAL INSPECTIONS OF THE CANNULA AND HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED THE CANNULA AND DIFFUSER CHAMBER OPENINGS TO BE CLEAR. 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: THE DEVICE COULD NOT BE CONFIRMED AS NEITHER ABLE NOR UNABLE TO SPRAY DURING THE EVALUATION, HOWEVER THIS COMPLAINT IS CONFIRMED BASED ON THE USER REPORT. THE REPORT INDICATES THAT THE DEVICE WAS UNABLE TO SPRAY DUE TO CLOGS CREATED FROM BLOOD IN THE CATHETER. THE BLOOD IN THE CATHETER WAS A RESULT OF THE USER APPLYING SUCTION TO THE CATHETER AT THE BLEEDING SITE, MAKING THIS A CASE OF USE ERROR. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE (IFU) 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 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 COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED, USE ERROR [ASPIRATION AND TOUCHING CATHETERS TO BLOOD] IS CONSIDERED THE ROOT CAUSE AND A COOK REPRESENTATIVE HAS CONTACTED THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THEY USED ANOTHER MANUFACTURER'S HEMOSTASIS CLIPS AND THEY DID NOT WORK. THEN THEY WENT DOWN [THE ENDOSCOPE] WITH THE HEMOSPRAY CATHETER AND LEFT SUCTION ATTACHED [SUCTION FUNCTION ON THE ENDOSCOPE]. THE PHYSICIAN SUCKED UP BLOOD, CAUSING THE POWDER TO BACK-FLOW INTO THE HEMOSPRAY HANDLE [VIA THE CATHETER, CATHETER CLOGGED] [SUBJECT OF THIS REPORT]. NO HEMOSPRAY WAS SUCCESSFULLY DEPLOYED AND THE PROCEDURE WAS STOPPED. THE PATIENT WAS IN THE INTENSIVE CARE UNIT AND HAD ALREADY BEEN INTUBATED. THE PATIENT EXPIRED AT SOME POINT DURING THE NIGHT IN THE INTENSIVE CARE UNIT. THE PHYSICIAN, NURSE MANAGER AND TECHNICIAN ACKNOWLEDGED THAT WHAT THEY DID WITH THE DEVICE WAS WRONG AND AGREED TO ADDITIONAL TRAINING. THEY DO NOT CONSIDER THE PATIENT'S DEATH TO BE THE RESULT OF A PRODUCT MALFUNCTION. 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 EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140410 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G56572 W4245319 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death