BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LC BEAD M1

    MDR report key: 4122389 · Received September 18, 2014

    Report

    Report Number
    3002124545-2014-00023
    Event Type
    Injury
    Date Received
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    /BIOCOMPATIBLES U.K. LIMITED
    Product Code
    HCG
    PMA / PMN Number
    094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LC BEAD WITH IRINOTECAN WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. LC BEAD IS NOT INDICATED FOR USE WITH IRINOTECAN. LC BEAD, IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, IT IS NOT POSSIBLE TO REVIEW THE BATCH, HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED GIVEN CASE INFORMATION. COMPANY MEDICAL ASSESSMENT: FOUR PATIENT WERE REPORTED TO HAVE EXPERIENCED "ABSCESSES" AFTER EMBOLISATION TREATMENT WITH LC M1 BEADS AT A SINGLE CENTER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME, ABOUT THE TYPE AND LOCATION OF THE ABSCESSES, WHETHER THE PATIENTS WERE HOSPITALIZED, HOW THEY WERE TREATED OR WHETHER THEY RECOVERED. THIS INFORMATION IS BEING SOUGHT. HOWEVER, SINCE THE TYPE OF ABSCESS MOST COMMONLY ASSOCIATED WITH BEAD EMBOLISATION THERAPY IS A HEPATIC ABSCESS, WHICH IS A SERIOUS ADVERSE EVENT THAT COULD HAVE OCCURRED DUE TO USER ERROR, THIS IS MEDICALLY REPORTABLE.

    Description of Event or Problem · 1

    INITIAL INFORMATION WS RECEIVED FROM A PHYSICIAN, VIA A COMPANY REPRESENTATIVE, REGARDING FOUR PATIENTS (UNIDENTIFIED PATIENT DETAILS) ON THE (B)(6) 2014. IT WAS REPORTED THAT FOUR PATIENT RECEIVED M1 DEBIRI (LC BEAD M1 WITH IRINOTECAN) AND EXPERIENCED POST-TREATMENT ABSCESSES ON AN UNKNOWN DATE IN 2014. THE OUTCOME OF POST - TREATMENT ABSCESSES WAS UNKNOWN AT THE TIME OF THIS REPORT. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT BETWEEN THE ABSCESSES AND LC BEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579085 LC BEAD M1 EMBOLI AGENT HCG /BIOCOMPATIBLES U.K. LIMITED LC BEAD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LC BEAD M1 LEADED WITH IRINOTECAN