BEUDAMED
    FDA Adverse Event Death Summary report: N

    DC BEAD

    MDR report key: 4637636 · Received February 26, 2015

    Report

    Report Number
    3002124545-2015-00008
    Event Type
    Death
    Date Received
    February 26, 2015
    Date of Event
    January 28, 2015
    Report Date
    February 26, 2015
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD WITH IRINOTECAN WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. THE CAUSE OF DEATH AND FORMAL DIAGNOSIS OF SEPSIS IS YET TO BE RECEIVED FROM THE REPORTER. NO PATHOGEN RELATED TO THE POSSIBLE SEPSIS COULD BE CONFIRMED DUE TO THE PROPHYLACTIC USE OF ANTIBIOTICS. FURTHER FOLLOW-UP INFORMATION IS BEING PURSUED. A REVIEW OF ALL PREVIOUSLY RECEIVED REPORTS OF SEPSIS WOULD SUGGEST THERE IS NO TREND OR INCREASE IN REPORTING RATES AND THEREFORE NO NEW SIGNAL HAS BEEN IDENTIFIED AND THIS IS LIKELY TO BE A PATIENT SPECIFIC INCIDENT. THIS IS AN INITIAL ASSESSMENT OF ROOT CAUSE, GIVEN THE INFORMATION GATHERED BY THE MANUFACTURER AT PRESENT. THE FINAL ROOT CAUSE ASSESSMENT WILL BE RECORDED FOLLOWING THE COMPLETION OF THE MANUFACTURER'S INVESTIGATION INTO THIS INCIDENT AND WILL BE COMMUNICATED AS FOLLOW UP REPORT. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    THIS CASE IS A COMBINATION OF INITIAL AND FOLLOW UP INFORMATION AND CONCERNS A (B)(6) MALE PATIENT. THE INFORMATION WAS RECEIVED FROM A PHYSICIAN VIA THE COMPANY MEDICAL SCIENCE LIAISON ON (B)(6) 2015; (B)(6) 2015 AND (B)(6) 2015 RESPECTIVELY. THE PATIENT HAD 50% TUMOR INVOLVEMENT, FEVER AT NIGHT RELATED TO CANCER AND ECOG 0. ON (B)(6) 2015, THE PATIENT RECEIVED DC BEAD (70-150UM) LOADED WITH IRINOTECAN 200MG FOR METASTATIC COLON CANCER. THE PHYSICIAN STATED THAT THE ADMINISTRATION PROCEDURE WAS COMPLETE WITHOUT COMPLICATIONS. FIVE HOURS AFTER ADMINISTRATION AND ON RETURN TO WARD, THE PATIENT EXPERIENCED HYPOTENSION AND HYPOTHERMIA. THE REPORTER STATED THAT IT IS LIKELY THAT THE PATIENT EXPERIENCED SEPTIC SHOCK WITH CARDIAC ARREST AND STATED THAT THE LETHAL ADVERSE EVENT OCCURRED ON (B)(6) 2015 AT 1AM FOR UNKNOWN REASON. THE REPORTER HAS STATED THAT NO AUTOPSY WAS REQUIRED. THE REPORTER HAS STATED THAT THE INFECTIOUS AGENT CAN'T BE IDENTIFIED DUE TO THE PATIENT BEING UNDER ANTIBIOPROPHYLAXIS (AUGMENTIN 1G/3). THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT BETWEEN DC BEAD AND SEPTIC SHOCK WITH CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138008 DC BEAD EMBOLIC AGENT HCG BIOCOMPATIBLES U.K. LIMITED 70-150UM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death