BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 4320956 · Received December 11, 2014

    Report

    Report Number
    3002124545-2014-00032
    Event Type
    Injury
    Date Received
    December 11, 2014
    Date of Event
    August 20, 2014
    Report Date
    November 19, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    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 AVM'S. THE USE OF EPIRUBICIN WITH DC BEAD IS CONSIDERED OFF-LABEL USE. THE DEVICE HAS NOT BEEN SENT TO THE MFR FOR EVAL. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE AS THE REPORTER DOES NOT SPECIFY LOT NUMBER. GIVEN THE CASE INFO CURRENTLY AVAILABLE, IT IS DIFFICULT FOR THE MFR TO ASSESS IF PRODUCT MALFUNCTION/DEFICIENCY HAS OCCURRED. MEDICAL ASSESSMENT: PT EXPERIENCED ABNORMAL LFT'S THAT WERE FELT TO CONSTITUTE A SERIOUS ADVERSE EVENT BY THE REPORTING PHYSICIAN SOON AFTER DEB-TACE. THESE ABNORMALITIES WERE RESOLVING. WHILE ABNORMAL LFT'S ARE AN EXPECTED COMPLICATION OF THIS PROCEDURE, THE MAGNITUDE OF ELEVATION THAT LED THE REPORTER TO LABEL THIS EVENT AS SERIOUS COULD BE CONSISTENT WITH USER ERROR (EG INADVERTENT PLACEMENT OF EMBOLIC BEADS IN MORE NORMAL LIVER TISSUE THAN IS USUAL) HENCE REPORTABLE. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MFR AND THE CONCLUSIONS OF THIS INVESTIGATION WILL BE COMMUNICATED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    THIS INITIAL REPORT CONCERNS A (B)(6) YEAR OLD MALE PT AND WAS RECEIVED FROM A USER FACILITY VIA A PARTNER ORGANIZATION ON (B)(6) 2014. THE PT'S CONCOMITANT DISEASES INCLUDE DIABETES MELLITUS AND CHRONIC RENAL FAILURE. ON (B)(6) 2014, THE PT UNDERWENT TACE PROCEDURE WITH DRUG-ELUTING DC BEAD (100-300UM) 1 VIAL LOADED WITH 50 MG OF EPIRUBICIN. IT WAS REPORTED THAT GELPART (POROUS GELATIN PARTICLES) WAS ALSO USED AS PART OF THE PROCEDURE. IN (B)(6) 2014 (BETWEEN (B)(6) 2014), THE PT DEVELOPED VAGAL REACTION, AND VAGAL REACTION RESOLVED ON THE SAME DAY (BETWEEN (B)(6) 2014). THE REPORTER STATED THAT THE EVENT WAS CONSIDERED NON-SERIOUS. ON THE (B)(6) 2014 THE PT EXPERIENCED AN INCREASE IN AST, ALT AND LDH. THE LABORATORY VALUES WERE NOT PROVIDED BUT THE REPORTER CLASSIFIED THE INCREASE AS SERIOUS ADVERSE EVENTS. THE PT WAS REPORTED TO BE RECOVERING FROM THE EVENT OF AST INCREASE ON THE (B)(6) 2014 AND THE EVENTS OF ALT AND LDH INCREASE WERE ASSESSED AS RESOLVING ON THE (B)(6) 2014. THE REPORTING PHYSICIAN ASSESSED THE EVENT OF VAGEL REACTION AS POSSIBLY RELATED TO DC BEAD AND THE EVENTS OF INCREASED AST, ALT, LDH AS PROBABLY RELATED TO DC BEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805828 DC BEAD EMBOLIC AGENT, HCG/KRD HCG BIOCOMPATIBLES U.K. LIMITED 100-300UM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other ATROPINE SULFATE HYDRATE (0.25MG WAS ADMINISTERED| AND TAURINE| LIDOCAINE,| INTRACENOUSLY),| EPIRUBICIN HYDROCHLORIDE 40MG,| CEFAZOLIN SODIUM,| IOMEPROL 350MG/ML,| GRANISETRON HYDROCHLORIDE,| MAGNESIUM OXIDE,| PROHEPARUM,| PENTAZOCINE,| EPIRUBICIN HYDROCHLORIDE 50MG,| URSODEOXYCHOLIC ACID,