BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEADF

    MDR report key: 4240384 · Received October 30, 2014

    Report

    Report Number
    3002124545-2014-00029
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 29, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LTD
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 TUMOURS AND AVMS. THE USE OF FARMORUBIC WITH DC BEAD IS CONSIDERED OFF-LABEL USE. THE DEVICE HAS NOT BEEN SENT TO THE MFR FOR EVALUATION. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE IF THE REPORTER DOES NOT SPECIFY LOT NUMBER. GIVEN CASE INFO CURRENT AVAILABLE, IT IS DIFFICULT FOR THE MFR TO ASSESS IF PRODUCT MALFUNCTION/DEFICIENCY HAS OCCURRED. MEDICAL ASSESSMENT: THE MEDICAL ASSESSMENT CONCLUDED THAT THE PT'S BILIRUBIN WAS 5.0 THE DAY AFTER THE DEB-TACE PROCEDURE AND ROSE FURTHER. THE BASELINE BILIRUBIN IS NOT PROVIDED. THE PT SUFFERED SERIOUS HARM. THIS MAY BE DUE TO USER ERROR IN TREATING A PT WHOSE LIVER FUNCTION WAS ALREADY TENUOUS. THIS EVENT IS MEDICALLY REPORTABLE.

    Description of Event or Problem · 1

    INITIAL AND FOLLOW UP INFO WAS RECEIVED FROM A USER FACILITY VIA A PARTNER ORGANIZATION ON (B)(6) 2014 RESPECTIVELY. CONCOMITANT DISEASE INCLUDE REFRACTORY PLEURAL EFFUSION ON (B)(6) 2014, TRANSCATHETER ARTERIAL EMBOLIZATION (TACE) WITH DC BEAD WAS PERFORMED. THREE FEEDER ARTERIES RAN TO THE TUMOR IN S4 LEGION AS IN THE PREVIOUS DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE ARTERY (A4 (1) BEFORE TAE WAS NOT WELL VISUALIZED IN DSA COMPARED TO THE PREVIOUS DSA IMAGE. A4 (2) AND (3) WAS EMBOLIZED, RESULTED IN A CLEAR VISUALIZATION. THE TUMOR STAIN WAS RESULTED IN A CLEAR VISUALIZATION. THE TUMOR STAIN WAS OBSERVED AT THE CAUDAL SIDE OF THE TUMOR AT A4 (2), (3) AND (1) IN DA AFTER PERFORMING TACE, AND FURTHER TACE WAS PERFORMED AT A4 (3). THE PT HAD 20 TIMES AND 10 TIMES DILUTED SOLUTION WITH HALF VOLUME OF FARMORUBIC. THE DOSES OF FAMORUBICIN WERE 9.25MG, 31.25 MG AND 5MG. ON (B)(6) 2014, THE PT'S BILIRUBIN WAS ELEVATED AND THE LEVE WAS CONTINUED TO RISE. AT THE TIME OF REPORTING THE PT WAS RECOVERING. THE PHYSICIAN STATED THE HYPERBILIRUBINEMIA WAS PROBABLE RELATED. ASPARTATE TRANSAMINASE (AST) AND ALANINE TRANSAMINASE (ALT) WERE DECREASING, BUT BILIRUBIN WAS CONTINUING TO INCREASE. THE CAUSE OF THE INCREASED BILIRUBIN WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695230 DC BEADF EMBOLIC AGENT HCG BIOCOMPATIBLES U.K. LTD 100-300UM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other FARMORUBIC 9.25MG, 31.25 MG AND 5MG.