BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMPOWER CTA

    MDR report key: 4929228 · Received July 9, 2015

    Report

    Report Number
    3004753774-2015-00001
    Event Type
    Death
    Date Received
    July 9, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 12, 2015
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    JAK
    PMA / PMN Number
    KO71378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMPOWERCTA SYSTEM INVOLVED IN THE EVENT IS THE FOLLOWING: INJECTOR UNIT SN: (B)(4), CONTROL PANEL SN: (B)(4), POWER SUPPLY SN: (B)(4) SOFTWARE VERSION 8. NO INFORMATION RECEIVED ON DISPOSABLES. NO DISPOSABLE RECEIVED DESPITE REQUEST. THE EMPOWERCTA AND DISPOSABLES HAVE BEEN REQUESTED TO BE SENT FOR INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED DESPITE OUR REQUEST AND THE CUSTOMER HAS ADVISED THAT THEY ARE CONDUCTING THEIR OWN INVESTIGATION. THEY ARE NOT READY TO RELEASE THE SYSTEM TO (B)(6) AND DO NOT HAVE A TIMELINE FOR DOING SO. BECAUSE THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION, WE ARE UNABLE AT THIS POINT TO PROVIDE ANY FURTHER PRELIMINARY ANALYSIS. HOWEVER THE CURRENT INFORMATION IS THE FOLLOWING. FIRST, THE END USER FACILITY INFORMED THAT THE PATIENT STARTED SUFFERING FROM SYMPTOMS 60 MINUTES POST ADMINISTRATION OF 100 ML OF ISOVUE. SECONDLY, THE END USER FACILITY CONFIRMED THAT THE EVENT WAS DUE TO AN ANAPHYLACTIC REACTION DUE TO ISOVUE 300 (IOPAMIDOL). GIVEN THE INVESTIGATION COMPLETION HAS BEEN MADE IMPOSSIBLE BECAUSE THE DEVICE HAS NOT BEEN RETURNED BY FACILITY AND SINCE THE ANAPHYLACTIC REACTION IS A KNOWN ADVERSE EVENT LINKED TO CONTRAST MEDIA DELIVERY, THE DEVICE IS THEREFORE NOT QUESTIONED AND NO SUBSEQUENT FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Additional Manufacturer Narrative · 1

    THE EMPOWERCTA SYSTEM INVOLVED IN THE EVENT IS THE FOLLOWING: INJECTOR UNIT SN: (B)(4), CONTROL PANEL SN: (B)(4), POWER SUPPLY SN: (B)(4) SOFTWARE VERSION 8. NO INFORMATION RECEIVED ON DISPOSABLES. NO DISPOSABLE RECEIVED DESPITE REQUEST. THE EMPOWERCTA AND DISPOSABLES HAVE BEEN REQUESTED TO BE SENT FOR INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED DESPITE OUR REQUEST AND THE CUSTOMER HAS ADVISED THAT THEY ARE CONDUCTING THEIR OWN INVESTIGATION. THEY ARE NOT READY TO RELEASE THE SYSTEM TO BRACCO INJENEERING AND DO NOT HAVE A TIMELINE FOR DOING SO. BECAUSE THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION, WE ARE UNABLE AT THIS POINT TO PROVIDE ANY FURTHER PRELIMINARY ANALYSIS. HOWEVER THE CURRENT INFORMATION ARE THE FOLLOWING. FIRST, THE END USER FACILITY INFORMED THAT THE PATIENT START SUFFERING FROM SYMPTOMS 60 MINUTES POST ADMINISTRATION OF 100 ML OF ISOVUE. SECONDLY, THE END USER FACILITY CONFIRMED THAT THE EVENT WAS DUE TO AN ANAPHYLACTIC REACTION DUE TO ISOVUE 300 (IOPAMIDOL). AS THERE IS NO INFORMATION THAT THE DEVICE WAS MALFUNCTIONING AND BECAUSE THE PATIENT SUFFERED FROM ANAPHYLACTIC REACTION, THE CURRENT STATUS IS THAT THE DEVICE IS NOT CAUSED OF THE ADVERSE EVENT. HOWEVER UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2015: A HEALTH PROFESSIONAL REPORTED AN ADVERSE EVENT WITH ISOVUE-300. ON (B)(6) 2015, (B)(6) RECEIVED ADDITIONAL INFORMATION FROM THE REPORTER AND SENT TO (B)(6) ON (B)(6) 2015. THIS INFORMATION WAS INCORPORATED INTO THIS INITIAL REPORT. A (B)(6) YEAR-OLD FEMALE PATIENT (WEIGHT (B)(6) KG) UNDERWENT A CONTRAST ENHANCED CT OF THE ABDOMEN AND PELVIS ON (B)(6) 2015 DUE TO RIGHT LOWER QUADRANT ABDOMINAL PAIN. ADDITIONAL MEDICAL HISTORY INCLUDED ALLERGY TO EGGS. IT WAS UNKNOWN WHETHER THE PATIENT HAD RECEIVED CONTRAST MEDIA PREVIOUSLY. THE PATIENT WAS NOT ON ANY MEDICATIONS CONCOMITANTLY. ON (B)(6) 2015, 60 MINUTES POST ADMINISTRATION OF 100 ML OF ISOVUE 300 (IOPAMIDOL) VIA UNSPECIFIED ROUTE, THE PATIENT STARTED COMPLAINING OF NOT FEELING WELL. THERE WAS NO HIVES OR SWELLING NOTED. THE PATIENT SAT UP AND HER EYES ROLLED INTO THE BACK OF THE HEAD AND SHE STARTED TO HAVE SEIZURES/CONVULSIONS AND HER MOUTH STARTED FOAMING. THE DIAGNOSIS OF SEVERE ANAPHYLACTIC REACTION WAS PROVIDED BY THE REPORTER. SHE WAS TAKEN TO THE EMERGENCY DEPARTMENT WHERE A "FULL-FLEDGED ALLERGY PROTOCOL" WAS GIVEN. AFTER AN UNKNOWN PERIOD IN THE EMERGENCY ROOM THE PATIENT EXPERIENCED CARDIORESPIRATORY ARREST. SHE WAS CODED (A MEDICAL EMERGENCY IN WHICH A TEAM OF MEDICAL PERSONNEL RESPOND) AND WAS "BROUGHT BACK". SHE WAS THEN AIR LIFTED TO ANOTHER FACILITY. TREATMENTS GIVEN WERE NOT SPECIFIED. ON THE SAME DAY ((B)(6) 2015), THE PATIENT EXPIRED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION IS REQUIRED. ON (B)(6) 2015: THE REPORTER WAS CONTACTED TO OBTAIN ADDITIONAL INFORMATION FOR THE REPORT. THE REPORTER STATED THAT HE WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION. ON (B)(6) 2015: THE REPORTER CONTACTED MULTIPLES TIMES TO OBTAIN ADDITIONAL INFORMATION FOR THE REPORT. THE REPORTER DID NOT RESPOND BACK TO EMAIL OR PHONE CALL. ON (B)(6) 2015: THE CUSTOMER HAS ADVISED THAT THEY ARE CONDUCTING THEIR OWN INVESTIGATION. THEY ARE NOT READY TO RELEASE THE SYSTEM TO (B)(6) AND DO NOT HAVE A TIMELINE FOR DOING SO.

    Description of Event or Problem · 1

    CAUSES OF DEATH: ANAPHYLACTIC REACTION NARRATIVE: ON (B)(6) -2015: A HEALTH PROFESSIONAL REPORTED AN ADVERSE EVENT WITH ISOVUE-300. ON (B)(6) 2015, BRACCO PARTNER ACIST RECEIVED ADDITIONAL INFORMATION FROM THE REPORTER AND SENT TO BRACCO ON (B)(6) 2015. THIS INFORMATION WAS INCORPORATED INTO THIS INITIAL REPORT. A (B)(6) FEMALE PATIENT ((B)(6)) UNDERWENT A CONTRAST ENHANCED CT OF THE ABDOMEN AND PELVIS ON (B)(6) 2015 DUE TO RIGHT LOWER QUADRANT ABDOMINAL PAIN. ADDITIONAL MEDICAL HISTORY INCLUDED ALLERGY TO EGGS. IT WAS UNKNOWN WHETHER THE PATIENT HAD RECEIVED CONTRAST MEDIA PREVIOUSLY. THE PATIENT WAS NOT ON ANY MEDICATIONS CONCOMITANTLY. ON (B)(6) 2015,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447909 EMPOWER CTA EMPOWER CTA JAK BRACCO INJENEERING S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death