BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 15179908 · Received August 5, 2022

    Report

    Report Number
    1037905-2022-00454
    Event Type
    Injury
    Date Received
    August 5, 2022
    Report Date
    September 21, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE . PRODUCT CODE: QAU. 510K: K200972. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE: PRODUCT CODE: QAU SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN TRAY 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. ALL COMPONENTS WERE INCLUDED IN THE RETURN. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN BETWEEN THE "ON" AND "OFF" POSITIONS. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. THE TWO RETURNED CATHETERS DID NOT PRESENT WITH ANY KINKS OR BENDS IN THEM, HOWEVER ONE OF THE CATHETERS HAD CLEAR FLUID INSIDE THE TUBING. THE DEVICE WAS TESTED AS RETURNED AND DID NOT SPRAY AS INTENDED. THE CO2 CARTRIDGE DID NOT DISCHARGE UPON DEACTIVATION AND WAS FULLY PUNCTURED. 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. WHEN TESTED WITH A NEW CO2 CARTRIDGE, THE DEVICE DID NOT SPRAY AS INTENDED. THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. LOOSE POWDER WAS PRESENT IN THE FRONT TUBE CONNECTING THE ON/OFF VALVE TO THE POWDER CHAMBER AND BACK TUBE CONNECTING THE POWDER CHAMBER TO THE LOW PRESSURE VALVE. A VISUAL INSPECTION OF THE HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THE LOW PRESSURE VALVE WAS DISASSEMBLED AND EVALUATED. ALL THE INTERNAL COMPONENTS WERE INTACT. HOWEVER, POWDER WAS OBSERVED AROUND THE BASE OF THE ACTIVATION BUTTON AND AROUND THE O-RINGS INSIDE THE VALVE. 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: POWDER WAS OBSERVED AROUND THE COMPONENTS AND O-RINGS INSIDE THE LOW PRESSURE VALVE. IT IS UNKNOWN HOW THE POWDER ENTERED THE VALVE. IT IS POSSIBLE THAT PRESSURE BACK FLOW OCCURRED DUE TO POWDER CLOGGING THE DEVICE AND/OR CATHETERS OR DUE TO THE CARBON DIOXIDE CARTRIDGE EMPTYING COMPLETELY, WHICH CAN SEND POWDER BACK INTO THE LOW PRESSURE VALVE AND CAUSE THE OBSERVATIONS FOUND DURING THE EVALUATION. THE REPORT INDICATES THAT THE CATHETERS WERE OCCLUDED, WHICH MAY HAVE CAUSED THE BACK FLOW OF POWDER; HOWEVER, THE RETURNED CATHETERS DID NOT CONTAIN ANY POWDER. 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 Manufacturer Narrative · 0

    CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU . SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN TRAY 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. ALL COMPONENTS WERE INCLUDED IN THE RETURN. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN BETWEEN THE "ON" AND "OFF" POSITIONS. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. THE TWO RETURNED CATHETERS DID NOT PRESENT WITH ANY KINKS OR BENDS IN THEM, HOWEVER ONE OF THE CATHETERS HAD CLEAR FLUID INSIDE THE TUBING. THE DEVICE WAS TESTED AS RETURNED AND DID NOT SPRAY AS INTENDED. THE CO2 CARTRIDGE DID NOT DISCHARGE UPON DEACTIVATION AND WAS FULLY PUNCTURED. 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. WHEN TESTED WITH A NEW CO2 CARTRIDGE, THE DEVICE DID NOT SPRAY AS INTENDED. THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. LOOSE POWDER WAS PRESENT IN THE FRONT TUBE CONNECTING THE ON/OFF VALVE TO THE POWDER CHAMBER AND BACK TUBE CONNECTING THE POWDER CHAMBER TO THE LOW PRESSURE VALVE. A VISUAL INSPECTION OF THE HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THE LOW PRESSURE VALVE WAS DISASSEMBLED AND EVALUATED. ALL THE INTERNAL COMPONENTS WERE INTACT. HOWEVER, POWDER WAS OBSERVED AROUND THE BASE OF THE ACTIVATION BUTTON AND AROUND THE O-RINGS INSIDE THE VALVE. 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: POWDER WAS OBSERVED AROUND THE COMPONENTS AND O-RINGS INSIDE THE LOW PRESSURE VALVE. IT IS UNKNOWN HOW THE POWDER ENTERED THE VALVE. IT IS POSSIBLE THAT PRESSURE BACK FLOW OCCURRED DUE TO POWDER CLOGGING THE DEVICE AND/OR CATHETERS OR DUE TO THE CARBON DIOXIDE CARTRIDGE EMPTYING COMPLETELY, WHICH CAN SEND POWDER BACK INTO THE LOW PRESSURE VALVE AND CAUSE THE OBSERVATIONS FOUND DURING THE EVALUATION. THE REPORT INDICATES THAT THE CATHETERS WERE OCCLUDED, WHICH MAY HAVE CAUSED THE BACK FLOW OF POWDER; HOWEVER, THE RETURNED CATHETERS DID NOT CONTAIN ANY POWDER. 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.

    Description of Event or Problem · 0

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) TO TREAT A DIVERTICULAR BLEED, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THE HEMOSPRAY PRODUCT MALFUNCTIONED AND THE CATHETERS FROM THE KIT CLOGGED /OCCLUDED. A PATIENT HAD A DIVERTICULAR BLEED, DOCTOR WAS UNABLE TO DETERMINE THE EXACT LOCATION OF DIVERTICULA THAT WAS BLEEDING. THE TRIGGER WAS ONLY PUSHED ONE TIME, AND NOTHING CAME OUT. IT APPEARED TO NOT HAVE CO2 IN THE CANNISTER [POWDER CLOGS VALVE - SUBJECT OF REPORT]. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NEED TO RECEIVE MEDICATION TO HELP STABILIZE HIS BLOOD PRESSURE WHILE RECEIVING DEEP SEDATION FOR 97 MINUTES FROM THE DELAY OF BEING ABLE TO STOP THE BLEEDING. 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
    263957 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G56572 W4570136 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ENDOSCOPE - UNKNOWN MAKE OR MODEL