BEUDAMED
    FDA Adverse Event Other Summary report: N

    DC BEAD

    MDR report key: 3878148 · Received June 13, 2014

    Report

    Report Number
    3002124545-2014-00013
    Event Type
    Other
    Date Received
    June 13, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 4, 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 LOADED WITH FARMORUBICIN (EPIRUBICIN HYDROCHLORIDE) WAS USED IN THE TREATMENT OF THIS PT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA BUT IS NOT INDICATED FOR THE USE WITH DRUGS. THE DEVICE HAS NOT BEEN SENT TO THE MFR FOR EVALUATION. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT: THIS IS A REPORT OF A PT WHO DEVELOPED PANCREATITIS AND GASTRODUODENAL ULCER SYMPTOMS THREE DAYS AFTER TREATMENT WITH DC BEAD AND FARMORUBICIN (EPIRUBICIN HYDROCHLORIDE) 150 MG. THE REPORTER HAS ASSESSED THE EVENT AS RELATED TO REFLUX OF DC BEAD INTO NON-TARGET VESSELS AND ASSESSED THE EVENTS AS SERIOUS. THESE EVENTS ARE CONSISTENT WITH ECTOPIC INJECTION OF BEADS DURING THE PROCEDURE AND THIS REPORT IS CONSIDERED MEDICALLY REPORTABLE. THESE SYMPTOMS WERE STABILIZED, AND THE PT WAS RECOVERING FROM THEM.

    Description of Event or Problem · 1

    THIS IS AN INITIAL REPORT RECEIVED ON THE (B)(4) 2014 FROM A HEALTH CARE PROFESSIONAL VIA A PARTNER ORGANISATION. THE REPORT IS REGARDING A PT OF UNK AGE AND GENDER WHO EXPERIENCED PANCREATITIS (DUE TO PANCREATIC INFARCTION) AND GASTRODUODENAL ULCER SYMPTOMS POST CHEMOEMBOLIZATION. THE PT UNDERWENT CHEMOEMBOLIZATION ON (B)(6) /2014 WITH DC BEAD 2 VIALS AND FARMORUBICIN (EPIRUBICIN HYDROCHLORIDE) 150 MG. ON (B)(6) 2014, APPROXIMATELY THREE DAYS POST PROCEDURE, THE PT EXPERIENCED PANCREATITIS (DUE TO PANCREATIC INFARCTION) AND GASTRODUODENAL ULCER SYMPTOMS. ON (B)(6) 2014, IT WAS CONFIRMED THAT THE SYMPTOMS WERE STABILIZED, AND THE PT WAS RECOVERING FROM THEM. NO INFO REGARDING TREATMENT OF THE ADVERSE EVENTS AS PROVIDED AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349580 DC BEAD EMBOLIC AGENT HCG BIOCOMPATIBLES U.K. LIMITED DC BEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FARMORUBICIN (EPIRUBICIN HYDROCHLORIDE) 150 MG