BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 4162723 · Received October 8, 2014

    Report

    Report Number
    3002124545-2014-00024
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    July 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LTD
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVAL. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION DEFICIENCY HAS BEEN IDENTIFIED. COMPANY MEDICAL ASSESSMENT: THIS REPORT INVOLVED A PT WHO SUFFERED A GASTROINTESTINAL BLEED DUE TO GASTRODUODENAL ULCERATION SHORTLY AFTER A DEB-TACE PROCEDURE. THE BLEEDING WAS REPORTED TO HAVE STOPPED, BUT THE PT WAS REPORTED TO HAVE SUFFERED SERIOUS CONSEQUENCES FROM THE RESULTING ANEMIA. IT CANNOT BE EXCLUDED THAT THIS EVENT WAS NOT DUE TO USER ERROR (I.E. ECTOPIC PLACEMENT OF EMBOLIC BEADS INTO THE GASTRODUODENAL ARTERY). ACCORDINGLY, THIS EVENT IS MEDICALLY REPORTABLE. THE EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND THE CONCLUSION OF THIS INVESTIGATION WILL BE COMMUNICATED AS A FOLLOW-UP TO THIS REPORT.

    Description of Event or Problem · 1

    THIS IS AN INITIAL REPORT RECEIVED FROM A USER FACILITY, VIA PT PARTNER ORGANIZATION ON (B)(6) 2014. ADDITIONAL INFO WAS ALSO RECEIVED ON THE (B)(6) 2014. THE REPORT CONCERNS AN (B)(6) OLD MALE PT WHO UNDERWENT A TACE PROCEDURE ON (B)(6) 2014. ON (B)(6) 2014, SIX DAYS POST TACE PROCEDURE THE PT DEVELOPED A SYMPTOM OF ANEMIA (DECEASED HAEMOGLOBIN). AN ENDOSCOPY WAS URGENTLY PERFORMED DUE TO MELENA, BUT SHOWED THAT THE MELENA HAD ALREADY RESOLVED. IT WAS REPORTED THAT THE PT EXPERIENCED A HAEMORRHAGIC GASTRODUODENAL ULCER (TIME TO ONSET UNREPORTED) AND THE PT RECOVERED. THE REPORTER GAVE NO INDICATION REGARDING WHETHER THE TWO EPISODES WERE LINKED AND FURTHER INFO HAS BEEN REQUESTED. THE REPORTER STATED THAT ULCER WAS POSSIBLY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633778 DC BEAD EMBOLIC AGENT, HCG/KRD HCG BIOCOMPATIBLES U.K. LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other