BEUDAMED
    FDA Adverse Event Other Summary report: N

    DC BEAD

    MDR report key: 3834835 · Received May 15, 2014

    Report

    Report Number
    3002124545-2014-00007
    Event Type
    Other
    Date Received
    May 15, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    KHC
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD LOADED WITH IRINOTECAN WAS USED IN THE TREATMENT OF THIS PT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA BUT IS NOT INDICATED FOR USE WITH DRUGS. 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 CONCLUDED THAT AT THIS TIME OF REPORTING THAT NO INFO REGARDING THE SEVERITY OF THIS EVENT HAS BEEN REC'D HOWEVER HEPATIC ENCEPHALOPATHY IS POTENTIALLY LIFE THREATENING, SO THIS EVENT HAS BEEN CONSERVATIVELY ASSESSED AS REPORTABLE ADD'L INFO REGARDING THIS CASE SPECIFICALLY INCLUDING THE TEMPORAL RELATIONSHIP BETWEEN THE PROCEDURE AND THE ONSET OF THE HEPATIC ENCEPHALOPATHY IS BEING SOUGHT TO ENABLE FURTHER INVESTIGATION. A REVIEW OF ALL COMPLAINTS OF THIS TYPE RELATING TO DC/LC BEAD BETWEEN 2004 AND APRIL 2014 WAS CARRIED OUT; NO OTHER COMPLAINTS OF THIS TYPE HAVE BEEN REPORTED TO BIOCOMPATIBLES/BTG.

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM A (B)(6) RADIOLOGIST REGARDING A PT (PT DETAILS UNK) WITH AN UNK INDICATION HAD TREATMENT WITH DEBIRI (DC BEAD WITH IRINOTECAN) AND EXPERIENCED HEPATIC ENCEPHALOPATHY. FURTHER REQUESTS FOR INFO MADE BUT NO ADD'L INFO REC'D FROM THE RADIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289421 DC BEAD EMBOLIC AGENT KHC BIOCOMPATIBLES UK LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening DC BEAD WAS LOADED WITH IRINOTECAN PRIOR TO USE.