BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 18095056 · Received November 8, 2023

    Report

    Report Number
    1037905-2023-00544
    Event Type
    Death
    Date Received
    November 8, 2023
    Report Date
    November 8, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. IN THE INSTRUCTIONS FOR USE (IFU), THE INTENDED USE OF THE DEVICE IS STATED TO BE "USED FOR HEMOSTASIS OF NONVARICEAL GASTROINTESTINAL BLEEDING." THE ARTICLE INDICATES THAT THE DEVICE WAS USED TO TREAT VARICEAL BLEEDS. 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 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 THROUGH A PMCF STUDY REPORT. THE PMCF PRESENTS A RETROSPECTIVE REVIEW OF DATA FROM AN OBSERVATIONAL POST-MARKET STUDY OF PATIENTS TREATED WITH HEMOSPRAY AND UTILIZES AGGREGATE RESULTS TAKEN FROM AN ONGOING GLOBAL REGISTRY INVESTIGATING THE OUTCOME OF THESE PATIENTS. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THE REPORT. "MULTIPLE CENTERS (USA, UK, FRANCE, GERMANY, SPAIN) PARTICIPATE IN THIS ONGOING GLOBAL REGISTRY, "AN INTERNATIONAL MULTICENTRE REGISTRY COLLECTING OUTCOMES OF PATIENTS WITH GASTROINTESTINAL BLEEDING UNDERGOING ENDOSCOPIC TREATMENT WITH HEMOSPRAY (THE 'HEMOSPRAY REGISTRY')"... DATA ON 205 CONSECUTIVE PATIENTS IN WHOM HEMOSPRAY WAS USED EITHER AS MONO OR DUAL THERAPY ALONG WITH OTHER MODALITIES BETWEEN FEBRUARY 2019 AND SEPTEMBER 2021 WERE COLLECTED AS PART OF THE PMCF STUDY... FOR THE PRIMARY PERFORMANCE OUTCOME OF INITIAL HEMOSTASIS, DATA ARE SUMMARIZED BY BLEEDING LOCATION. OVERALL, 179/192 (93.2%; 95% CI, 88.7%-96.4%) PATIENTS WITH AVAILABLE INFORMATION ACHIEVED INITIAL HEMOSTASIS... FOR THE OUTCOME OF INITIAL HEMOSTASIS, 13 PATIENTS EXPERIENCED FAILURE. OF THESE FAILURES, 2 PATIENTS PASSED AWAY [PATIENT DEATH -SUBJECT OF REPORT]... THE TWO (2) PATIENT (2/205, 1.0%) DEATHS WERE REPORTED DUE TO PERSISTENT GASTRIC VARICEAL BLEEDING. HEMOSPRAY WAS USED AS MONOTHERAPY IN BOTH PATIENTS. AS PREVIOUSLY NOTED, USE OF HEMOSPRAY TO TREAT VARICEAL BLEEDING IS CONSIDERED AN OFF-LABEL USE... NO DEVICE-RELATED ADVERSE EVENTS (DEFINED AS EMBOLIZATION OF THE POWDER, INTESTINAL OBSTRUCTION, ALLERGY TO HEMOSPRAY) WERE REPORTED IN THIS DATA SET OF 205 PATIENTS..." IT WAS NOT REPORTED IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. TWO PATIENT DEATHS WERE REPORTED DUE TO PERSISTENT GASTRIC VARICEAL BLEEDING. HEMOSPRAY WAS USED AS MONOTHERAPY IN BOTH PATIENTS. AS PREVIOUSLY NOTED, USE OF HEMOSPRAY TO TREAT VARICEAL BLEEDING IS CONSIDERED AN OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276959 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

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