BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 18634057 · Received February 2, 2024

    Report

    Report Number
    1037905-2024-00064
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    August 22, 2022
    Report Date
    February 2, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: 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. HOWEVER, A DEVICE FAILURE WAS NOT REPORTED. THE INSTRUCTIONS FOR USE (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.

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE. THIS ARTICLE WAS PUBLISHED IN 2013. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "THIS IS A RETROSPECTIVE COHORT STUDY OF ADULTS WHO PRESENTED WITH GIB AND RECEIVED HEMOSPRAY AS A PRIMARY OR A SALVAGE MODALITY FOR ENDOSCOPIC HEMOSTASIS FROM JANUARY 1, 2019 TO AUGUST 22, 2022 IN A SINGLE, TERTIARY CARE CENTER. THE PRIMARY OUTCOME WAS IMMEDIATE HEMOSTASIS. SECONDARY OUTCOMES WERE RE-BLEEDING RATE, BLOOD TRANSFUSION REQUIREMENT, LENGTH OF STAY, AND MORTALITY. A TOTAL OF 55 PATIENTS WERE INCLUDED. THE MEDIAN AGE WAS 57.0 (IQR, 49.0, 67.0), 37 PATIENTS (67%) WERE MALES, AND 48 PATIENTS (87%) WERE HISPANICS... THE RE-BLEEDING RATE WAS NOT SIGNIFICANTLY DIFFERENT, WITH NO IMMEDIATE COMPLICATIONS REPORTED IN BOTH GROUPS." PER THE PUBLISHED TABLE, IN 1 PATIENT THEY WERE UNABLE TO ACHIEVE IMMEDIATE HEMOSTASIS AS SALVAGE MODALITY [SUBJECT OF THIS REPORT]. IT WAS NOT REPORTED IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. IT WAS NOT PUBLISHED WHAT ADDITIONAL PROCEDURES WERE REQUIRED TO STOP THE BLEEDING. IT WAS PUBLISHED THAT NO IMMEDIATE COMPLICATIONS WERE REPORTED IN BOTH GROUPS. CHAVEZ, L., ET. AL. HTTPS://DOI.ORG/10.1016/J.GIE.2023.04.1882.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278207 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

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