BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 8316261 · Received February 7, 2019

    Report

    Report Number
    1037905-2019-00049
    Event Type
    Death
    Date Received
    February 7, 2019
    Date of Event
    January 19, 2019
    Report Date
    January 21, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PMA/510(K)# : DEN170015. THE LOT NUMBER COULD NOT BE SPECIFIED BY THE INITIAL REPORTER. UPON REVIEW OF THIS FACILITY'S ORDER HISTORY, WE CONFIRMED THE OCCURRENCE INVOLVES ONE OF THE THREE FOLLOWING LOT NUMBERS: (B)(4), MANUFACTURE DATE 12/17/2018, EXPIRATION DATE 12/11/2021; (B)(4), MANUFACTURE DATE 12/13/2018, EXPIRATION DATE 12/07/2021; (B)(4), MANUFACTURE DATE 11/15/2018, EXPIRATION DATE 11/08/2021. 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 POTENTIAL LOT NUMBERS SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: THE LIKELY ROOT CAUSE OF THIS REPORT IS USER ERROR; THE TIP OF THE CATHETER TOUCHED BLOOD, WHICH RESULTED IN A CLOG. WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE FOLLOWING INFORMATION WAS PROVIDED REGARDING THE USE OF THE DEVICE, "WHEN HE PUT THE SCOPE INTO THE ESOPHAGUS, IT WAS A COMPLETE VISUAL RED OUT DUE TO THE AMOUNT OF BLOOD INSIDE THE ESOPHAGUS. HE TRIED HEMOSPRAY AS A LAST DITCH EFFORT TO TRY AND SAVE THE PATIENT¿S LIFE. THE CATHETER CLOGGED DUE TO THE COPIOUS AMOUNT OF BLOOD EXITING THE ESOPHAGUS." THE INSTRUCTIONS FOR USE STATE THE FOLLOWING PROCEDURAL STEP, "BEFORE INSERTING CATHETER INTO ACCESSORY CHANNEL, IDENTIFY BLEEDING SITE, REMOVE AS MUCH BLOOD AS POSSIBLE, THEN FLUSH ACCESSORY CHANNEL WITH AIR." THE REPORT FURTHER INDICATES, ¿PER CUSTOMER, THEY PLACED THE HEMOSPRAY CATHETER DOWN IN THE PATIENT AND THE CATHETER GOT BLOOD INSIDE OF IT. CATHETER WAS CLOGGED.¿ TO ASSIST THE USER, THE INSTRUCTIONS FOR USE STATE THE FOLLOWING, "PRECAUTION: TO AVOID CATHETER OCCLUSION, DO NOT PLACE CATHETER DIRECTLY IN CONTACT WITH BLOOD AND/OR MUCOSA, INCLUDING ANY POOLED BLOOD AND DO NOT ASPIRATE BLOOD WHILE CATHETER IS IN ACCESSORY CHANNEL... NOTE: IF CATHETER BECOMES OCCLUDED, TURN RED VALVE TO CLOSED POSITION, REMOVE CATHETER FROM ENDOSCOPE AND REPLACE WITH EXTRA CATHETER PROVIDED IN PACKAGE." 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: 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE CATHETER CAME IN CONTACT WITH BLOOD, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING AN EMERGENCY HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE PATIENT CAME TO EMERGENCY ROOM FROM ANOTHER HOSPITAL, AND HAD RECEIVED SIX (6) UNITS OF BLOOD ALREADY. THE PATIENT HAD BEEN AIRLIFTED TO THE FACILITY. WHEN THE ENDOSCOPY TEAM GOT TO THE PATIENT, THE PATIENT WAS IN "BAD SHAPE", PER CUSTOMER. THE PUPILS WERE DILATED, LIKELY HEMODYNAMICALLY UNSTABLE. THE ENDOSCOPY TEAM TRIED TO FIND THE SOURCE OF BLEEDING SOMEWHERE IN ESOPHAGUS. THERE WAS "SO MUCH BLOOD" IN THE ESOPHAGUS THAT THEY COULD NOT FIND THE SOURCE [OF BLEEDING]. DURING TREATMENT, PATIENT RECEIVED THIRTY (30) UNITS [OF BLOOD]. PER THE CUSTOMER, THEY PLACED THE HEMOSPRAY CATHETER DOWN IN THE PATIENT AND THE CATHETER GOT BLOOD INSIDE OF IT. CATHETER WAS CLOGGED. THEY PULLED CATHETER OUT [OF THE ENDOSCOPE] AND TRIED TO UNCLOG CATHETER. IT WAS UNCLEAR WHETHER THE SECOND CATHETER WAS EVER USED. PER THE COOK DISTRICT MANAGER (DM), THE PATIENT WAS "CRASHING TOO QUICKLY." THE PATIENT EXPIRED. PER THE DM, THE CUSTOMER DID NOT BELIEVE THIS [THE PATIENT DEATH] WAS A FAULT OF THE DEVICE, AND WERE NOT COMPLAINING ABOUT THE DEVICE. THE USER WANTED TO PASS ALONG AS AN "FYI" OF THE OCCURRENCE. THE DM WENT TO THE FACILITY TO DO FOLLOW UP WITH STAFF AND GAIN DETAILS. THE FOLLOWING WAS RECEIVED 25-JAN-2019: I HAD THE OPPORTUNITY TO SPEAK DIRECTLY WITH THE ENDOSCOPY PHYSICIAN WHO ATTEMPTED TO USE HEMOSPRAY ON THE PATIENT WHO PASSED AWAY. HE SAID, BY THE TIME ENDOSCOPY WAS CALLED TO THE EMERGENCY ROOM, THE PATIENT¿S EYES WERE FIXED AND UNRESPONSIVE. WHEN HE PUT THE ENDOSCOPE INTO THE ESOPHAGUS, IT WAS A COMPLETE VISUAL RED-OUT [NO ENDOSCOPIC VISIBILITY] DUE TO THE AMOUNT OF BLOOD INSIDE THE ESOPHAGUS. HE TRIED HEMOSPRAY AS A LAST DITCH EFFORT TO TRY AND SAVE THE PATIENT¿S LIFE. THE CATHETER CLOGGED DUE TO THE COPIOUS AMOUNT OF BLOOD EXITING THE ESOPHAGUS. THE PATIENT WAS NEAR DEATH WHEN ENDOSCOPY BECAME INVOLVED AND ATTEMPTED TO USE HEMOSPRAY. THE NURSE SAID A STEADY STREAM OF BLOOD WAS COMING OUT OF THE PATIENT¿S MOUTH BEFORE INTUBATION AND DURING THE ENDOSCOPY. THE CAUSE OF DEATH IS UNKNOWN, BUT SPECULATED BY THE PHYSICIAN TO BE AN AORTIC RUPTURE IN THE ESOPHAGUS DUE TO ESOPHAGEAL CANCER. NO OTHER HEMOSTASIS MODALITIES WERE ATTEMPTED SINCE THE PATIENT WAS NEAR DEATH. PER THE PHYSICIAN'S PROFESSIONAL OPINION, THERE WAS NOTHING THAT WOULD HAVE PREVENTED THE PATIENT'S DEATH, BUT THE USERS FELT THE NEED TO TRY HEMOSPRAY AS A LAST FINAL RESORT. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT EXPIRED; HOWEVER, ACCORDING TO THE INITIAL REPORTER, THEY DID NOT BELIEVE THE PATIENT DEATH IS A FAULT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111471 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ENDOSCOPE, UNKNOWN MAKE AND MODEL