BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 14834598 · Received June 27, 2022

    Report

    Report Number
    1037905-2022-00320
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    January 1, 2019
    Report Date
    July 25, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. 510K: K200972. THIS ARTICLE IS UNDER INVESTIGATION. A FOLLOW UP EMDR WILL BE SENT TO CAPTURE THE COMPLETED INVESTIGATION. PLEASE NOTE THAT SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT EVENTS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION. HTTPS://DOI.ORG/10.1080/00365521.2020.1853219.

    Additional Manufacturer Narrative · 0

    SECTION D_ COMMON DEVICE NAME_ HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE_ QAU SECTION G_ 510K_ K200972 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. 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: 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. HTTPS://DOI.ORG/10.1080/00365521.2020.1853219.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THIS ARTICLE IS UNDER REVIEW AND INVESTIGATION. A FOLLOW UP EMDR WILL BE SENT TO CAPTURE THE PERTINENT INFORMATION AND COMPLETED INVESTIGATION. PLEASE NOTE THAT SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT EVENTS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION. THE FOLLOWING WAS PUBLISHED IN A CLINICAL LITERATURE ARTICLE INVOLVING COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. HTTPS://DOI.ORG/10.1080/00365521.2020.1853219. THE PATIENT UNDERWENT TO EGD SHOWING A SMALL FORREST III ULCER ON THE GASTROJEJUNAL ANASTOMOSIS AND ACTIVE BLEEDING COMING FROM THE ENTIRE MUCOSA OF THE GASTRIC POUCH; THE OOZING AREA WAS SO LARGE THAT, THEREFORE, A TREATMENT WITH HEMOSPRAY (COOK MEDICAL-HEMOSPRAY ENDOSCOPIC HEMOSTAT) WAS DONE. TWO WEEKS LATER, DUE TO A NEW EPISODE OF HEMATEMESIS, AN EMERGENCY EGD WAS PERFORMED, SHOWING A FRIABLE AND HYPEREMIC MUCOSA OF THE ANASTOMOSIS AS ACTIVE BLEEDING PERSISTED, A TREATMENT WITH HEMOSPRAY WAS ATTEMPTED, WITHOUT SUCCESS INITIAL HEMOSTASIS WAS ACHIEVED (100%) DURING THE FIRST PROCEDURE. HEMOSTASIS WAS NOT ACHIEVED (0%) WITH SUBSEQUENT HEMOSPRAY COMBINATION THERAPY. NO UNDESIRABLE SIDE EFFECTS WERE REPORTED BY THE AUTHORS. UNABLE TO ACHIEVE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910647 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

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