BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 8883921 · Received August 12, 2019

    Report

    Report Number
    1037905-2019-00458
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 17, 2019
    Report Date
    July 18, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE. COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. INFORMATION REGARDING PMA/510K: DEN170015. 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 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.

    Description of Event or Problem · 1

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. DURING HEMOSTASIS OF A DUODENAL ULCER, THE POWDER WAS SPRAYED. THE PATIENT'S REACTION APPEARED "PAINFUL" TO THE STAFF. ABOUT THE TIME THE POWDER WAS DEPLOYED, IT APPEARED THE PATIENT "WINCED/TIGHTENED UP". THE USER WAS ABLE TO COMPLETE THE PROCEDURE AS INTENDED, BUT PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT. THE FOLLOWING DAY, A PERFORATION WAS DISCOVERED IN THE PATIENT THAT MAY HAVE BEEN THE CAUSE OF THE DISCOMFORT/PAIN. THE USER IS UNSURE WHETHER PATIENT REACTION WAS DUE TO PERFORATION OR AN ALLERGIC REACTION. IT IS UNKNOWN IF THE PERFORATION WAS THERE PREVIOUSLY, OR IF IT WAS MADE DURING THE PROCEDURE." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, BUT POTENTIAL CLOSING OF THE PERFORATION MAY BE PERFORMED IN THE FUTURE. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING POTENTIAL ADDITIONAL PROCEDURES WAS UNSUCCESSFUL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676407 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY UNKNOWN

    Patients

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