BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 4260700 · Received November 13, 2014

    Report

    Report Number
    3002124545-2014-00030
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 8, 2014
    Report Date
    November 12, 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 TUMOURS AND AVMS. THE USE OF FARMORUBICIN WITH DC BEAD IS CONSIDERED OFF-LABEL USE. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVAL. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE IF THE REPORTER DOES NOT SPECIFY LOT NUMBER. GIVEN CASE INFO CURRENTLY AVAILABLE, IT IS DIFFICULT FOR THE MANUFACTURER TO ASSESS IF PRODUCT MALFUNCTION/DEFICIENCY HAS OCCURRED. MEDICAL ASSESSMENT: THE MEDICAL ASSESSMENT CONCLUDED THAT THE PT APPARENTLY SUFFERED RUPTURE OF HEPATIC TUMOR AND MEDICALLY SIGNIFICANT SERIOUS BLEEDING SOON AFTER DEB-TACE. WHILE LESION RUPTURE IS IN THE PRODUCT IFU, IT IS NOT POSSIBLE TO DEFINITELY RULE OUT THAT DEVICE MALFUNCTION OR USER ERROR COULD HAVE CONTRIBUTED TO THE EVENT AND IS THEREFORE REPORTABLE. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND THE CONCLUSION OF THIS INVESTIGATION WILL BE COMMUNICATED AS A F/U REPORT.

    Description of Event or Problem · 1

    THIS INITIAL REPORT CONCERNS A (B)(6) FEMALE PT AND WAS RECEIVED FROM A USER FACILITY VIA A PARTNER ORGANIZATION ON (B)(4) 2014. ON UNK DATES, THE PT HAD THREE TACE PROCEDURES (UNK COMBINATIONS). ON (B)(6) 2014 AT 11:00, THE PT HAD THE FOURTH TACE PROCEDURE. GASTROEPIPLOIC ARTERY WAS EMBOLIZED WITH EMBOSPHERE. MANY TUMORS WERE DETECTED IN THE LIVER PARENCHYMA, AND THE MAXIMUM TUMOR DIMENSIONS WERE 133 X 65 M, 31 X 48 MM, 26 X 26 MM, 11 X 11 MM AND 26 X 26 MM. EMBOLIZATION OF THE RIGHT AND LEFT HEPATIC ARTERIES WAS PERFORMED WITH DC BEAD 2 VIALS (RIGHT: 7CC AND LEFT: 33CC). TRANSCATHETER EMBOLIZATION WAS PERFORMED TO DECREASE VASCULARITY. THE PROCEDURE WAS COMPLETED, ALTHOUGH BLOOD SINUS WERE OBSERVED. AT 14:00 THE PT WENT BACK TO HER ROOM WITH NORMAL VITAL SIGNS. AT 19:44, VOMITING AND RIGHT SHOULDER PAIN DEVELOPED, AND NSAIDS WERE GIVEN. ON (B)(6) 2014, AT 03:33, ANOTHER PT WHO WAS IN THE SAME ROOM FOUND THE PT IN A CROUCHING POSITION UNDER THE BED. THE PT HAD NO CONTUSION. THE PT HAD EXCESSIVE SWEATING, AND FELT DIZZY. THE PT GOT ON THE BED BY HERSELF. 74/40; P 60. AT 05:13, THE PT COMPLAINED OF FEELING EXHAUSTED. 72/86; P85. FLUID RESUSCITATION WAS COMMENCED. AT 05:13, AN URGENT COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND THE RESULTS REVEALED RUPTURE IN THE AREA OF HEPATIC INFARCTION. THE DIMENSION OF RUPTURED AREA WAS AROUND 62 X 102 MM. AT THE TIME OF THIS REPORT, THE PT WAS IN THE HOSP WITH LIVER SUPPORTING THERAPY AND THE PT DID NOT RECOVER. THE PHYSICIAN STATED AREA AFFECTED THE SURROUNDING HEPATIC PARENCHYMA, POSSIBLY LEADING TO HEPATIC RUPTURE AND THAT HEPATIC RUPTURE WAS PROBABLY RELATED. THE PHYSICIAN STATED THAT "REPEATED VOMITING MAY AFFECT THE OCCURRENCE OF ADVERSE EVENT AND MAY INCREASE THE INTRA-ABDOMINAL PRESSURE AND BLOOD VESSELS. ROUTINE PROCEDURE WAS PERFORMED, AND INVESTIGATION FOR THE BACKGROUND ON THE OCCURRENCE OF THE PHENOMENON IS NEEDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733921 DC BEAD EMBOLIC AGENT, HCG/KRD HCG BIOCOMPATIBLES U.K. LIMITED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization EMBOSPHERE| FARMORUBICIN