BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 21303332 · Received February 4, 2025

    Report

    Report Number
    1037905-2025-00092
    Event Type
    Death
    Date Received
    February 4, 2025
    Date of Event
    October 1, 2024
    Report Date
    February 4, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    PMA / PMN Number
    K200972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THERE IS NO EVIDENCE TO SUGGEST THE REPORT IS DUE TO A DEVICE FAILURE. THE IFU PRECAUTIONS "ENSURE GASTROINTESTINAL LUMEN IS NOT DISTENDED BECAUSE HEMOSPRAY ADDS VOLUME IN EXCESS OF INSUFFLATION VOLUMES DURING PROCEDURE. CLOSELY MONITOR BOWEL DISTENSION AND BALANCE INSUFFLATION AND HEMOSPRAY VOLUMES AS NECESSARY." ADDITIONALLY, 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 HEMOSTAT 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. THIS REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE. THIS ARTICLE WAS PUBLISHED IN 2024. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. PERFORATION DUE TO CO2 INSUFFLATION GASTROINTESTINAL PERFORATION HAS BEEN REPORTED AS A RARE ADVERSE EVENT OF TC-325 [HEMOSPRAY] USE. A 90-YEAR-OLD WOMAN WITH A HISTORY OF STROKE (ON ASPIRIN) WAS SENT TO THE EMERGENCY DEPARTMENT FROM SUB-ACUTE REHABILITATION FOR HYPOTENSION, LETHARGY, AND DARK STOOL. UPON ARRIVAL, HER VITAL SIGNS WERE TEMPERATURE 36.4C, BLOOD PRESSURE 76/45 MMHG, HEART RATE 143 BPM, OXYGEN SATURATION 94% ON A NON-REBREATHER. HER LABS SHOWED: HEMOGLOBIN 4.4 G/DL, PLATELETS 210 X 103 PLATELETS/UL, BLOOD UREA NITROGEN 51 MG/DL, CREATININE 0.64 MG/DL, PROTHROMBIN TIME 14.5 SECONDS, ACTIVATED PARTIAL THROMBOPLASTIN TIME 27.3 SECONDS. SHE RECEIVED INTRAVENOUS FLUID RESUSCITATION AND 3 UNITS OF PACKED RED BLOOD CELLS WITH STABILIZATION OF HER VITAL SIGNS. THE FOLLOWING DAY, ESOPHAGOGASTRODUODENOSCOPY SHOWED ACTIVE BLEEDING IN THE PRESENCE OF SEVERE EROSIVE ESOPHAGITIS IN THE HIATAL HERNIA SAC AND 4 NONOBSTRUCTING OOZING LINEAR GASTRIC ULCERS IN THE GASTRIC FUNDUS AND LESSER CURVATURE OF THE GASTRIC BODY. A FORREST IB LINEAR FUNDIC ULCER, 10MM IN LARGEST DIMENSION, WAS NOTED AND SUCCESSFULLY APPROXIMATED WITH 2 HEMOSTATIC CLIPS. GIVEN THE PERSISTENCE OF ACTIVE BLEEDING FROM AN UNCLEAR SOURCE THE PATIENT WAS INTUBATED FOR AIRWAY PROTECTION AND TC-325 [HEMOSPRAY} WAS APPLIED BROADLY IN THE PROXIMAL STOMACH AND HERNIA SAC. DURING THIS PHASE OF THE PROCEDURE THE PATIENT ACUTELY DEVELOPED A DISTENDED, TYMPANITIC ABDOMEN. HER VENTILATION WORSENED REQUIRING HIGHER POSITIVE END-EXPIRATORY PRESSURE, AND SHE EXPERIENCED INTRAPROCEDURAL CARDIAC ARREST. ADVANCED CARDIAC LIFE SUPPORT MEASURES WERE INITIATED; NEEDLE DECOMPRESSION WAS PERFORMED FOR TENSION CAPNOPERITONEUM WHICH IMMEDIATELY IMPROVED HER VENTILATION. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT LATER EXPIRED AND AUTOPSY WAS DECLINED. GASTRIC PERFORATION AND TENSION CAPNOPERITONEUM FOLLOWING HEMOSTATIC POWDER SPRAY APPLICATION BRIAN MCSTEEN, MD THE AMERICAN JOURNAL OF GASTROENTEROLOGY VOLUME 119 - SUPPLEMENT - OCTOBER 2024 WWW.AMJASTRO.COM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57424 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G56572 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Death