BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 10795919 · Received November 5, 2020

    Report

    Report Number
    1037905-2020-00470
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 15, 2020
    Report Date
    December 9, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002210493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT SOURCE OTHER: MEDWATCH REPORT NUMBER: MW 5097373 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. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. 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 INCLUDE THE FOLLOWING POTENTIAL COMPLICATION: "WHEN SPRAYING IN RETROFLEXED POSITION, HEMOSPRAY POWDER MAY ADHERE TO THE OUTSIDE OF THE ENDOSCOPE. THIS MAY RESULT IN DIFFICULTY REPOSITIONING/REMOVING THE ENDOSCOPE, PARTICULARLY IF PASSING THROUGH A STRICTURED AREA." WHILE SCOPE ADHERENCE TO THE ESOPHAGUS IS MORE LIKELY TO OCCUR IN RETROFLEXED POSITION, IT IS NOT EXCLUSIVE TO THIS SCOPE POSITION AND HAS BEEN SEEN TO OCCUR IN OTHER SCOPE POSITIONS AS WELL. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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 · 0

    THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA: "DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT "A LOT OF BLOOD AND THERE WERE CLOTS BLOCKING THE LOWER ESOPHAGEAL SPHINCTER." THE HEMOSPRAY POWDER USED TO TREAT THE BLEED IN THAT AREA CAUSED THE ENDOSCOPE TO STICK TO THE PATIENT'S ESOPHAGEAL MUCOSA. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT WITH THE ENDOSCOPE IN THEIR MOUTH; HOWEVER THE PATIENT WAS NOT HOSPITALIZED NOR WAS THERE PROLONGED HOSPITALIZATION. THE USER CHOSE TO LET THE PATIENT'S ESOPHAGEAL SECRETIONS HYDRATE THE POWDER AND THEN THE ENDOSCOPE COULD BE REMOVED." ADDITIONAL INFORMATION AS RECEIVED VIA MEDWATCH REPORT MW5097373 ON 30-NOVEMBER-2020 WHICH STATES: PATIENT HAD A LARGE ESOPHAGEAL BLEED, THE MEDICAL DOCTOR (MD) HAD DIFFICULTY STOPPING BLEEDING IN A GASTROINTESTINAL (GI) PROCEDURE. THE PHYSICIAN USED THE HEMOSPRAY PRODUCT VIA A GI SCOPE WITH SUCCESSFUL BLEEDING CONTROL. THE MD ATTEMPTED TO REMOVE THE SCOPE AND FOUND IT ADHERED TO THE PATIENT'S ESOPHAGUS. THE MD OPTED TO LEAVE THE SCOPE IN OVERNIGHT TO ALLOW THE PATIENT'S SECRETIONS TO LOOSEN IT; THE SCOPE WAS REMOVED THE FOLLOWING MORNING WITHOUT INCIDENT. THE PRODUCT REP CONFIRMS THAT THERE WAS NO MISUSE OF THE PRODUCT NOTED. THE PRODUCT REP AND THE MD BELIEVE THAT DUE TO THE COLLECTION OF BLOOD AND LARGE DISTAL CLOT THAT THE ESOPHAGUS FORMED A 'CLOSED SYSTEM"; WHEN THE HEMOSPRAY WAS INTRODUCED INTO THE SYSTEM. IT RESULTED IN "BLOWBACK", WHERE THE PRODUCT SETTLED BETWEEN THE SCOPE AND ESOPHAGUS. THE INSTRUCTIONS FOR USE (IFU) LISTS THIS IS AS A POSSIBILITY WHEN THE SCOPE IS IN THE RETROFLEXED POSITION. HOWEVER, THAT WAS NOT THE CASE AT THE TIP. THE REP REPORTED ONE OTHER SIMILAR KNOWN INSTANCE THAT OCCURRED IN (B)(6); IN THAT SITUATION, THE MD ALSO OPTED TO LEAVE THE SCOPE IN OVERNIGHT FOR THE SAME PURPOSES. THE REP HAD SUGGESTED PERHAPS ADDING WATER TO THE ESOPHAGUS TO LOOSEN THE SCOPE. HOWEVER MD FEARED THIS WOULD AFFECT HEMOSTASIS AND MIGHT HAVE CAUSED BLEEDING TO RESUME. THE PATIENT WAS TRANSFERRED TO THE ICU OVERNIGHT WITH THE ENDOSCOPE ADHERED TO THE PATIENT'S ESOPHAGUS. THE ENDOSCOPE WAS REMOVED THE FOLLOWING MORNING WITHOUT INCIDENT BY THE PATIENT'S SECRETIONS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE: COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE PRODUCT CODE: QAU INITIAL REPORTER OCCUPATION - NON-HEALTHCARE PROFESSIONAL. INFORMATION REGARDING PMA/510(K): 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. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. 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 INCLUDE THE FOLLOWING POTENTIAL COMPLICATION: "WHEN SPRAYING IN RETROFLEXED POSITION, HEMOSPRAY POWDER MAY ADHERE TO THE OUTSIDE OF THE ENDOSCOPE. THIS MAY RESULT IN DIFFICULTY REPOSITIONING/REMOVING THE ENDOSCOPE, PARTICULARLY IF PASSING THROUGH A STRICTURED AREA." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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 AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT "A LOT OF BLOOD AND THERE WERE CLOTS BLOCKING THE LOWER ESOPHAGEAL SPHINCTER." THE HEMOSPRAY POWDER USED TO TREAT THE BLEED IN THAT AREA CAUSED THE ENDOSCOPE TO STICK TO THE PATIENT'S ESOPHAGEAL MUCOSA. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT WITH THE ENDOSCOPE IN THEIR MOUTH; HOWEVER THE PATIENT WAS NOT HOSPITALIZED NOR WAS THERE PROLONGED HOSPITALIZATION. THE USER CHOSE TO LET THE PATIENT'S ESOPHAGEAL SECRETIONS HYDRATE THE POWDER AND THEN THE ENDOSCOPE COULD BE REMOVED. OTHER THAN THE HEMOSPRAY POWDER, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    1254988 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G21049 W4368500 00827002210493

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS 2TH180 ENDOSCOPE