BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 21840302 · Received April 15, 2025

    Report

    Report Number
    1037905-2025-00284
    Event Type
    Death
    Date Received
    April 15, 2025
    Date of Event
    January 16, 2025
    Report Date
    May 9, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    PMA / PMN Number
    K200972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION E PHONE: (B)(6). 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. HOWEVER, A DEVICE FAILURE WAS NOT REPORTED. BASED ON THE RECEIVED INFORMATION, THE PATIENTS SUFFERED A REBLEED AFTER SUCCESSFUL HEMOSTASIS. THE IFU STATES, "ALL ENDOSCOPIC HEMOSTATIC THERAPIES, INCLUDING HEMOSPRAY, HAVE AN ASSOCIATED RISK OF REBLEEDING, PARTICULARLY IN SITUATIONS WHERE THE CAUSE OF BLEEDING IS AN UNRESOLVED UNDERLYING DISEASE. AFTER HEMOSTASIS HAS BEEN ACHIEVED, MONITOR PATIENTS FOR REBLEEDING PER THE RELEVANT CLINICAL GUIDELINES." THE IFU PRECAUTIONS, "LIKE OTHER MODALITIES, HEMOSPRAY MAY NOT BE EFFECTIVE FOR ALL TYPES OF BLEEDS. GASTROINTESTINAL BLEEDING MAY EXACERBATE EXISTING COMORBIDITIES, INCREASING THE POTENTIAL FOR ADVERSE EVENTS INCLUDING PATIENT MORTALITY." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION E PHONE: (B)(6). 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 PROCEDURE TO TREAT A BLEEDING ULCER IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE PATIENT HAD BEEN REPEATEDLY BLEEDING FROM A DUODENAL ULCER FOR THREE DAYS, AND PRIOR TO THIS TREATMENT, HE HAD BEEN TREATED WITH CLIPS TO STOP THE BLEEDING TWICE. DUE TO ANEMIA, LOW BLOOD PRESSURE, AND TARRY STOOLS, THE PHYSICIAN UNDERWENT ANOTHER ENDOSCOPY. THERE WAS A LARGE AMOUNT OF BLOOD CLOTS AND BLEEDING FROM THE DUODENAL ULCER. THEY USED TWO CLIPS AND SPRAYED WITH HEMOSPRAY. AT THAT POINT, THE BLEEDING HAD STOPPED, BUT ABOUT 9 HOURS LATER, BLOOD PRESSURE DROPPED DUE TO RE-BLEEDING, AND AN ENDOSCOPY WAS PERFORMED. DUE TO GUSHING BLEEDING, IT WAS NOT POSSIBLE TO STOP THE BLEEDING, AND THE SCOPE WAS REMOVED BECAUSE THE PATIENT'S VITALS COLLAPSED, AND THE PATIENT DIED WITHOUT BEING ABLE TO UNDERGO SURGERY OR AG TREATMENT. PER THE PHYSICIAN, "I BELIEVE THAT THE CAUSE OF REBLEEDING WAS THE EXCESSIVE STIMULATION OF EXPOSED BLOOD VESSELS BY APPLYING CLIPS, AND THE FACT THAT THE HEMOSTATIC AGENT WAS NOT DISTRIBUTED PROPERLY DUE TO THE PRESENCE OF CLIPS AT THE BLEEDING SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126641 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G56572 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death ENDOSCOPE - UNKNOWN MAKE OR MODEL| HEMOSTATIC CLIP-UNKNOWN MODEL