BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 24338507 · Received February 13, 2026

    Report

    Report Number
    1037905-2026-00080
    Event Type
    Injury
    Date Received
    February 13, 2026
    Report Date
    February 13, 2026
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    PMA / PMN Number
    K200972
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO FURTHER INVESTIGATE POWDER ADHERENCE TO THE DISTAL END OF THE SCOPE. THIS DEVICE IS WITHIN THE SCOPE OF THE CAPA. TO ASSIST THE USER THE IFU STATES: "WHEN SPRAYING IN RETROFLEXED POSITION, HEMOSPRAY POWDER MAY ADHERE TO THE OUTSIDE OF THE ENDOSCOPE. THIS MAY RESULT IN DIFFICULTY REPOSITIONING/REMOVING THE ENDOSCOPE, PARTICULARLY IF PASSING THROUGH A STRICTURED AREA." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE POWDER ADHERENCE TO THE DISTAL END OF THE SCOPE. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. 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. HEMOSTATIC HOLD-UP: A RARE CASE OF ENDOSCOPIC RETENTION AFTER HEMOSTATIC POWDER APPLICATION CARLOS ECHEVERRIA, MD1, JAHNAVI UDAIKUMAR, MD1, JAD FARHA, MD2, AND MAYSAA EL ZOGHBI, MD2 DOI:10.14309/CRJ.0000000000001981.

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE. THIS ARTICLE WAS PUBLISHED ONLINE JAN 2026. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. A 74-YEAR-OLD WOMAN WITH CHRONIC KIDNEY DISEASE, ATRIAL FIBRILLATION, MECHANICAL AORTIC AND MITRAL VALVES ON WARFARIN, AND A HISTORY OF GASTRIC ULCERS PRESENTED TO THE EMERGENCY DEPARTMENT WITH MELENA AND LARGE VOLUME HEMATEMESIS WITH HEMODYNAMIC INSTABILITY. LABORATORY FINDINGS WERE NOTABLE FOR A HEMOGLOBIN OF 7.3 AND AN INTERNATIONAL NORMALIZED RATIO (INR) OF 7 REQUIRING TRANSFUSION OF 2 UNITS OF RED BLOOD CELLS IN ADDITION TO 2 DOSES OF 10 MG IV VITAMIN K WITH SUBSEQUENT IMPROVEMENT OF INR TO 2.6. NO FRESH FROZEN PLASMA OR ADDITIONAL BLOOD PRODUCTS WERE ADMINISTERED. ESOPHAGOGASTRODUODENOSCOPY (EGD) REVEALED MULTIPLE ACTIVELY BLEEDING AVMS IN THE CARDIA AND FUNDUS (FIGURE 1). THE AVMS WERE FIRST TREATED WITH PURASTAT GEL. GIVEN RESIDUAL OOZING AND PERSISTENT COAGULOPATHY, HEMOSPRAY WAS SUBSEQUENTLY APPLIED FROM A RETROFLEXED POSITION AS A CONTACT-FREE ADJUNCT IMMEDIATELY AFTER PURASTAT PLACEMENT. ON ATTEMPTED WITHDRAWAL, THE SCOPE TIP AND DISTAL SHAFT WERE NOTED TO BE COATED WITH POWDER, AND RESISTANCE WAS ENCOUNTERED. WITHOUT FURTHER ATTEMPTS AT PHYSICAL MANIPULATION, A PROLONGED PERIOD OF COPIOUS IRRIGATION WITH WATER (;90 MINUTES FROM THE TIME RESISTANCE WAS FIRST ENCOUNTERED TO FINAL WITHDRAWAL) ULTIMATELY MOBILIZED THE ADHERENT MATERIAL, PERMITTING SAFE REMOVAL. ALTERNATIVE STRATEGIES BEYOND IRRIGATION WERE NOT DOCUMENTED, AND NO SURGICAL CONSULTATION WAS OBTAINED. AFTER THE PROCEDURE, THE PATIENT REMAINED INTUBATED IN THE ICU WHERE SHE RECEIVED 1 ADDITIONAL UNIT OF RED BLOOD CELLS AND OCTREOTIDE GIVEN HER MULTIPLE AVMS. NO OVERT GASTROINTESTINAL BLEEDS WERE NOTED POSTOPERATIVELY. WARFARIN WAS RESUMED 5 DAYS AFTER THE PROCEDURE WITH INR GOAL OF 2.5¿3.5. THE IMMEDIATE POST PROCEDURE COURSE WAS UNCOMPLICATED, WITH NO RECURRENT INTRA PROCEDURAL BLEEDING AFTER SCOPE REMOVAL. THE HOSPITALIZATION WAS SUBSEQUENTLY PROLONGED BY 2 EPISODES OF INTRACEREBRAL HEMORRHAGE RELATED TO ANTICOAGULATION, WITHOUT FURTHER GASTROINTESTINAL BLEEDING. THE PATIENT WAS ULTIMATELY LOST TO OUTPATIENT FOLLOW-UP, LIMITING ASSESSMENT OF LONG-TERM OUTCOMES. THE MECHANISM OF SCOPE ADHERENCE IN THIS CASE IS LIKELY MUL-TIFACTORIAL. THE COMBINATION OF PURASTAT, WHICH POLYMERIZES ON MUCOSAL CONTACT, AND HEMOSPRAY, A BENTONITE-BASED POWDER THAT ABSORBS WATER AND CONCENTRATES CLOTTING FACTORS, MAY HAVE CREATED AN ADHESIVE MATRIX BINDING TO THE ENDOSCOPE TIP. THE RETROFLEXED POSITION IN THE GASTRIC CARDIA/FUNDUS INCREASED MUCOSAL CONTACT WITH THE COATED SHAFT, PLAUSIBLY CONTRIBUTING TO RESISTANCE ON WITHDRAWAL. HEMOSTATIC HOLD-UP: A RARE CASE OF ENDOSCOPIC RETENTION AFTER HEMOSTATIC POWDER APPLICATION DOI:10.14309/CRJ.0000000000001981.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393215 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G56572 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female ENDOSCOPE - UNKNOWN MAKE OR MODEL| PURASTAT