BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 4792285 · Received April 28, 2015

    Report

    Report Number
    3002124545-2015-00025
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    November 7, 2014
    Report Date
    April 27, 2015
    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

    (B)(4). DC BEAD WITH EPIRUBICIN HYDROCHLORIDE 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 HYDROCHLORIDE IS CONSIDERED OFF-LABEL USE. THE DEVICE HAS NOT BEEN SENT TO THE MFR 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: PT DEVELOPED JAUNDICE (BILIRUBIN 22) AND INCREASED TRANSAMINITIS FOLLOWING A DEB-TACE PROCEDURE, THIS PROLONGED THE HOSPITALIZATION. PT ON COURSE FOR A COMPLETE RECOVERY, THIS EVENT IS A MEDICALLY REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MFR AND THE CONCLUSION OF THIS INVESTIGATION/ANY NEW INFO RECEIVED WILL BE COMMUNICATED AS A F/U REPORT. SEE SCANNED PAGE.

    Additional Manufacturer Narrative · 1

    COMPANY MEDICAL ASSESSMENT: THE PATIENT DEVELOPED JAUNDICE (BILIRUBIN ABOVE 22) AND TRANSAMINITIS FOLLOWING A DEB-TACE PROCEDURE. THIS PROLONGED HOSPITALIZATION. PATIENT ON COURSE FOR A COMPLETE RECOVERY. THIS IS A MEDICALLY REPORTABLE EVENT. MANUFACTURER ANALYSIS: A BATCH RECORD REVIEW AND VISUAL INSPECTION OF A RETAINED SAMPLE COULD NOT BE PERFORMED AS NO BATCH NUMBER FOR THE COMPLAINT HAS BEEN PROVIDED. THE COMPANY REPORTING AND MEDICAL ASSESSMENTS CONCLUDED THAT THE COMPLAINT WAS MEDICALLY REPORTABLE DUE TO THE PATIENT'S HOSPITAL STAY BEING PROLONGED. THE REPORTING PHYSICIANS STATED POSSIBLE CAUSAL FACTORS APART FROM DC BEAD TO BE FARMORUBICIN (EPIRUBICIN HYDROCHLORIDE) AND GELPART (POROUS GELATIN PARTICLES). COMPANY ROOT CAUSE ANALYSIS ALSO ASSESSED THAT THE DEB-TACE PROCEDURE ITSELF COULD HAVE CONTRIBUTED TO THE EVENT. HOWEVER, NO SINGULAR ROOT CAUSE WAS IDENTIFIED ON THIS OCCASION. NO DEVICE FAILURE OR MALFUNCTION HAS BEEN IDENTIFIED AS A RESULT OF THIS INVESTIGATION. NO CAPAS HAVE BEEN IDENTIFIED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP AND FINAL REPORT PROVIDING THE MANUFACTURER FINAL ANALYSIS. ON (B)(6) 2014 THE PATIENT ALSO DEVELOPED PYREXIA AND WAS TREATED WITH LOXOPROFEN (LOXOPROFEN SODIUM HYDRATE) WAS ORALLY TAKEN. THE EVENTS OF AST AND ALT INCREASED PROLONGED THE PATIENT'S HOSPITALIZATION. HOWEVER IT WAS CONFIRMED THAT ON (B)(6) 2014 THE AST AND ALT INCREASED WERE RESOLVING AND (B)(6) 2014 THE PYREXIA WAS RESOLVING. ON (B)(6) 2014 IT WAS IDENTIFIED THAT THE PATIENT'S BILIRUBIN HAD INCREASED AND A FURTHER INTRAVENOUS INJECTION OF KAYTWO N WAS GIVEN THE EVENT BEGAN RESOLVING IN (B)(6) 2014.

    Description of Event or Problem · 1

    INITIAL INFO CONCERNING A (B)(6) MALE PT AND WAS RECEIVED FROM A PHYSICIAN VIA THE COMPANY DISTRIBUTOR ON (B)(6) 2015. THE PT'S MEDICAL HISTORY WAS UNK AND CONCOMITANT MEDICATIONS INCLUDED IOPAMIDOL, DIAZEPAM AND PENTAZOCINE. CONCOMITANT DISEASE INCLUDED HYPERTENSION, HYPERLIPIDAEMIA, CHILD-PUGH CLASSIFICATION: A. ON (B)(6) 2014, TACE WAS PERFORMED USING ONE VIAL OF DC BEAD (100-300 UM) LOADED WITH 75 MG OF FARMORUBICIN (EPIRUBICIN HYDROCHLORIDE), THE PROCEDURE ALSO INCLUDED GELPART (POROUS GELATIN PARTICLES). ON (B)(6) 2014, ONE DAY AFTER THE PROCEDURE, THE PT DEVELOPED ASPARATE AMINOTRANSFERASE (AST) INCREASE AND ALANINE AMINOTRANSFERASE (ALT) INCREASE (HOSPITALIZED OR PROLONGED HOSPITALIZATION) AND THE PT RECEIVED INTRAVENOUS INJECTION OF KAYTWO N (MENATETRENONE). ON (B)(6) 2014, THE PT EXPERIENCED PYREXIA (NON-SERIOUS) AND THE PT RECEIVED LOXOPROFEN (LOXOPROFEN SODIUM HYDRATE) ORALLY. AS OF (B)(6) 2014, THE PT WAS RECOVERING FROM AST INCREASE AND ALT INCREASE AND AS OF (B)(6) 2014, THE PT WAS RECOVERING FROM PYREXIA. ON (B)(6) 2014, THE PT BILIRUBIN INCREASE (HOSPITALIZED OR PROLONGED HOSPITALIZATION) AND THE PT RECEIVED INTRAVENOUS INJECTION OF KAYTWO N. AS OF (B)(6) 2014, THE PT'S BILIRUBIN INCREASE WAS RESOLVING. THE REPORTING PHYSICIAN STATED THAT THE EVENTS PYREXIA, AST INCREASED, ALT INCREASED, BILIRUBIN INCREASE WERE POSSIBLY RELATED TO DC BEAD. THE REPORTING PHYSICIAN ALSO STATED THAT THE CAUSATIVE FACTORS OTHER THAN DC BEAD WERE CONSIDERED TO BE FARMORUBICIN (EPIRUBICIN HYDROCHLORIDE) AND GELPART (POROUS GELATIN PARTICLES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278820 DC BEAD EMBOLIC AGENT HCG BIOCOMPATIBLES U.K. LTD. 100 - 300 UM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization DIAZEPAM| PENTAZOCINE