BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 15192402 · Received August 9, 2022

    Report

    Report Number
    1037905-2022-00460
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    July 1, 2022
    Report Date
    September 2, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. PMA/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 A BIOBAG. NO LOT INFORMATION WAS PROVIDED WITH THE RETURN. 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 THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. CATHETER #1 PRESENTED WITH DISCOLORED POWDER INSIDE THE TUBING, MINOR KINKS, AND POWDER ON THE RED HUB. CATHETER #2 PRESENTED WITH RED SUBSTANCE AND FLUID INSIDE THE TUBING, POWDER ON THE RED HUB, AND THE DISTAL TIP OF THE CATHETER WAS ANGLED AND MISSING PRINT, INDICATING THAT THE CATHETER WAS CUT. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE CO2 CARTRIDGE DID NOT DISCHARGE UPON DEACTIVATION AND WAS FULLY PUNCTURED. 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. WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE SPRAYED AS INTENDED. THE RETURNED CATHETERS WERE ATTACHED FOR TESTING. CATHETER #1 SPRAYED AS INTENDED. WHEN CATHETER #2 WAS TESTED, THE DISTAL TIP INITIALLY DISCHARGED BROWN/GRAY FLUID, AND THEN PROCEEDED TO SPRAY AS INTENDED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: THE LABORATORY EVALUATION OF THE RETURNED DEVICE INDICATED THAT THE CATHETER CONTAINED FLUID AND POWDER THAT CREATED DIFFICULTY FOR POWDER TO EXIT THE DEVICE. THE RETURNED DEVICE SPRAYED AS INTENDED WITHOUT THE USE OF CATHETERS AND WITH THE USE OF CATHETER #1, AND CATHETER #2 SPRAYED AFTER EXPELLING FLUID. THE LIKELY CAUSE OF THE CLOGGED CATHETER IS RELATED TO BLOOD OR OTHER FLUID FROM THE SURROUNDING AREA CLOGGING THE DEVICE DUE TO USE ERROR. THIS IS INDICATED BY THE FLUID FOUND IN THE CATHETER THAT WAS EXPELLED DURING FUNCTIONAL TESTING. 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." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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 THAT FLUID AND POWDER WERE FOUND IN THE CATHETER, THE LIKELY CAUSE OF THE CLOGGED CATHETER IS RELATED TO BLOOD OR OTHER FLUID FROM THE SURROUNDING AREA CLOGGING THE DEVICE DUE TO USE ERROR. THE INSTRUCTIONS FOR USE STATE, "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." A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT 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 · 0

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT A LARGE BLEEDING ULCER IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT WHEN THE BUTTON WAS PUSHED ON THE DEVICE, NO NOISE OR POWDER EXITED FROM THE CATHETER [DIFFICULT OR UNABLE TO SPRAY]. THEY TRIED BOTH CATHETERS, BUT ENDED UP ABORTING THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PHYSICIAN USED OLYMPUS ENDOCLOT SOLUTION TO FINISH THE PROCEDURE 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
    1941391 HEMOSPRAY ENDOSCOPIC HEMOSTAT Hemostatic device for endoscopic gastrointestinal use QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention ENDOSCOPE - UNKNOWN MAKE OR MODEL.