BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSPHERE®

    MDR report key: 23851847 · Received December 19, 2025

    Report

    Report Number
    1721504-2025-00770
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    December 2, 2024
    Report Date
    December 19, 2025
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    HCG
    UDI-DI
    00884450402948
    PMA / PMN Number
    K181300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE REPORTED THAT DURING INJECTION OF THE EMBOSPHERE MICROSPHERES, THE PATIENT DEVELOPED SEVERE THORACIC AND ABDOMINAL PAIN WITH EACH INJECTION. WITHIN APPROXIMATELY 30 MINUTES AFTER THE PROCEDURE, THE PATIENT DEVELOPED ORTHOPNEA, CONFUSION, AND AGITATION. LABORATORY TESTS SHOWED MARKED ELEVATIONS IN HIGH-SENSITIVITY TROPONIN, MYOGLOBIN, CREATINE KINASE, AND CK-MB, CONSISTENT WITH AN ACUTE MYOCARDIAL INFARCTION. BRAIN MRI REVEALED NUMEROUS BILATERAL ACUTE INFARCTS IN THE CEREBRAL HEMISPHERES AND BASAL GANGLIA, CONSISTENT WITH PARADOXICAL CEREBRAL EMBOLIZATION. NO DEVICE MALFUNCTION IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259106 EMBOSPHERE® EMBOLIZATION PARTICLE, NON-BIOABSORBABLE HCG BIOSPHERE MEDICAL, S.A. 00884450402948

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention