BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 4379999 · Received December 3, 2014

    Report

    Report Number
    3002124545-2014-00034
    Event Type
    Injury
    Date Received
    December 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    December 2, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD 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 TUMOURS AND AVMS. THE USE OF EPIRUBICIN WITH DC BEAD IS CONSIDERED OFF-LABEL USE. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE AS THE REPORTER DOES NOT SPECIFY LOG NUMBER. GIVEN THE CASE INFORMATION CURRENTLY AVAILABLE, IT IS DIFFICULT FOR THE MANUFACTURER TO ASSESS IF PRODUCT MALFUNCTION/DEFICIENCY HAS OCCURRED. MEDICAL ASSESSMENT: PATIENT DEVELOPED SEVERE LOWER GASTROINTESTINAL BLEEDING SIX DAYS AFTER A DEB-TACE PROCEDURE. THE PATIENT HAD A HISTORY OF DIVERTICULAR BLEEDING AND THIS EVENT WAS ALSO ATTRIBUTED BY THE REPORTER TO BE DUE TO DIVERTICULAR BLEEDING. HOWEVER, WHILE THIS IS MOST LIKELY CAUSE, ONE CAN'T COMPLETELY RULE OUT THAT THE EVENT WAS INSTEAD COLONIC BLEEDING TO ISCHEMIA DUE TO INADVERTENT EMBOLISATION OF A NON-TARGET ARTERY, WHICH WOULD CONSTITUTE A USER ERROR. ACCORDINGLY, THIS EVENT WAS CONSIDERED MEDICALLY REPORTABLE. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND THE CONCLUSIONS OF THIS INVESTIGATION WILL BE COMMUNICATED AS A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE POTENTIAL CONTRIBUTORY FACTORS WERE INVESTIGATED AND ASSESSED AS PART OF THIS COMPLAINT. ALTHOUGH THE PATIENT HAD A HISTORY OF DIVERTICULAR BLEEDING, AN INADVERTENT EMBOLIZATION OF A NON-TARGET ARTERY DURING THE PROCEDURE CAN'T BE EXCLUDED; THIS CONSTITUTES USER ERROR DUE TO NON-TARGET EMBOLIZATION. NON-TARGET EMBOLIZATION IS EXPECTED AND DOCUMENTED WITHIN THE PRODUCT RISK ANALYSES AND IFUS.

    Description of Event or Problem · 1

    THIS INITIAL REPORT CONCERNS A (B)(6) YEAR OLD MALE PATIENT AND WAS RECEIVED FROM A USER FACILITY VIA A PARTNER ORGANIZATION ON (B)(6) 2014. CONCOMITANT DISEASE INCLUDE: HEPATIC CIRRHOSIS (TYPE C), TYPE 2 DIABETES MELLITUS AND CHRONIC RENAL FAILURE. ON (B)(6) 2014, THE PATIENT HAD TAE WITH EMBOSPHERE (TRISACRYL GELATIN MICROSPHERES). ON (B)(6) 2014, TACE WAS PERFORMED WITH DRUG-ELUTING DC BEAD (100-300 M); 1 VIAL LOADED WITH 50MG OF EPIRUBICIN. ON (B)(6) 2014, APPROXIMATELY 6 DAYS AFTER THE DEB-TACE PROCEDURE, THE PATIENT DEVELOPED LOWER GASTROINTESTINAL HAEMORRHAGE (COLONIC DIVERTICULAR BLEEDING) AND THE PATIENT EXPERIENCE A MASSIVE MELENA. THE PATIENT'S HAEMOGLOBIN LEVEL WAS DECREASED FROM 11.5 G/DL TO 5.4 G/DL AND THE PATIENT RECEIVED A BLOOD TRANSFUSION OF IR-RCC-LR-II (800ML). ON (B)(6) 2014, THE PATIENT UNDERWENT A GASTROINTESTINAL FIBERSCOPY (GIF) AND THE RESULTS WERE NEGATIVE. ON (B)(6) 2014, THE PATIENT'S COLONOSCOPY (CF) REVEALED DIVERTICULA IN THE SIGMOID COLON. ON AN UNKNOWN DATE IN (B)(6) 2014 (WITHIN THE SAME WEEK), THE PATIENT'S DIVERTICULAR BLEEDING STOPPED ON ITS OWN. ON (B)(6) 2014, THE PATIENT RECOVERED FROM THE LOWER GASTROINTESTINAL HAEMORRHAGE (COLONIC DIVERTICULAR BLEEDING). THE REPORTING PHYSICIAN STATED THAT LOWER GASTROINTESTINAL HAEMORRHAGE (COLONIC DIVERTICULAR BLEEDING) WAS NOT RELATED TO DC BEAD. THE PHYSICIAN ATTRIBUTED THE EVENTS TO THE UNDERLYING DISEASE AND STATED THAT THE EVENT WAS ACCIDENTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782101 DC BEAD EMBOLIC AGENT HCG/KRD HCG BIOCOMPATIBLES U.K. LTD 100-300UM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other EMBOSPHERE (TRISACRYL GELATIN MICROSPHERES).| INSULIN HUMAN (GENETICAL RECOMBINATION)| IOVERSOL 350MG/ML AND