BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 14844457 · Received June 28, 2022

    Report

    Report Number
    1037905-2022-00344
    Event Type
    Death
    Date Received
    June 28, 2022
    Report Date
    June 28, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. PMA/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. A DEVICE FAILURE WAS NOT REPORTED. IT IS UNKNOWN WHEN THE PERFORATION OCCURRED, HOWEVER IT IS POSSIBLE THE HEMOSPRAY DEVICE CONTRIBUTED TO THE PERFORATION DUE TO INSUFFLATION. ENDOSCOPE INSUFFLATION IS ALSO A POTENTIAL CAUSE OF THE PERFORATION. THE INSTRUCTIONS FOR USE (IFU) ADDRESS POTENTIAL CLINICAL PROCEDURE RELATED COMPLICATIONS, INCLUDING A CAUTION RELATED TO DISTENTION OF THE STOMACH: "PRECAUTION: ENSURE GASTROINTESTINAL LUMEN IS NOT DISTENDED BECAUSE HEMOSPRAY ADDS VOLUME IN EXCESS OF INSUFFLATION VOLUMES DURING PROCEDURE." THE IFU ALSO INCLUDES THE FOLLOWING INFORMATION RELATED TO THE OCCURRENCE OF PERFORATION: [HEMOSPRAY IS] "ALSO CONTRAINDICATED IN PATIENTS WHO HAVE GASTROINTESTINAL FISTULAS, ARE SUSPECTED OF HAVING A GASTROINTESTINAL PERFORATION, OR ARE AT HIGH RISK OF GASTROINTESTINAL PERFORATION DURING ENDOSCOPIC TREATMENT." THE IFU INDICATES THE FOLLOWING POTENTIAL COMPLICATIONS: "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION..." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTAT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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. RANDOMIZED CONTROLLED TRIAL OF HEMOSTATIC POWDER VERSUS ENDOSCOPIC CLIPPING FOR NON-VARICEAL UPPER GASTROINTESTINAL BLEEDING. HTTPS://DOI.ORG/10.1007/S00464-019-06769-Z.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN A CLINICAL LITERATURE ARTICLE INVOLVING COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. "ARTICLE STATED RANDOMIZED CONTROLLED TRIAL USING HEMOSPRAY FOR THE TREATMENT OF PATIENTS WITH NVUGIB..... THERE WAS ONE DIALYTIC PATIENT ADMITTED IN THE EMERGENCY DEPARTMENT WITH REFRACTORY HEMODYNAMIC INSTABILITY, WHO PRESENTED A SEVERE SPURTING BLEEDING LACERATION LOCATED IN DISTAL ESOPHAGUS, INTERPRETED AS A MALLORY-WEISS TEAR. A FEW MINUTES AFTER HEMOSPRAY APPLICATION, HE SHOWED SIGNS OF ABDOMINAL DISTENSION, AND THE ATTENDING PHYSICIAN FOR A DECOMPRESSIVE NASOGASTRIC TUBE, WHICH LED TO AN EARLY REBLEEDING (PROBABLY CAUSED BY THE REMOVAL OF HEMOSTATIC POWDER AFTER TUBE POSITIONING) AND DEATH. AFTERWARD, AUTOPSY SHOWED THAT ABDOMINAL DISTENSION WAS DUE TO PERFORATION OF DISTAL ESOPHAGUS (BEFORE OR DURING HEMOSPRAY THERAPY)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909963 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death