BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPASPHERE

    MDR report key: 25322975 · Received May 28, 2026

    Report

    Report Number
    9615728-2026-00074
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    December 18, 2025
    Report Date
    May 28, 2026
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    KRD
    PMA / PMN Number
    K172372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT MEETS FDA CRITERIA FOR REPORTING. THE REPORT IS BEING SUBMITTED TO ENSURE ACCURACY AND COMPLETENESS OF MDR FILES. THIS SUBMISSION DOES NOT REFLECT A CHANGE IN DEVICE PERFORMANCE OR PATIENT RISK. THE AWARENESS DATE CORRESPONDS TO WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT DETAILS. ALL INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THIS TIME HAS BEEN INCLUDED. NO PHYSICAL UNITS WERE RECEIVED FOR EVALUATION IN RELATION TO THIS COMPLAINT; HOWEVER, PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER IN RELATION TO THIS REPORTED EVENT. IN THE PHOTOS PROVIDED, THE FLUID APPEARS TO BE VISCOUS AND PASTY IN THE VIAL AS REPORTED BY THE CUSTOMER. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. THE ACTUAL DEVICE WAS NOT RETURNED, THEREFORE, THE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING THE DRUG PREPARATION STAGE, THE CHEMOTHERAPY DRUG IDARUBICIN WAS LOADED ACCORDING TO THE STANDARD PREPARATION METHOD. AFTER SHAKING, THE MIXED SOLUTION BECAME VISCOUS AND PASTY. THE MICROCATHETER WAS EXTRACTED AND DILUTED FOR EMBOLIZATION AND BLOCKAGE, WHICH LED TO THE INABILITY TO COMPLETE THE EMBOLIZATION SURGERY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227069 HEPASPHERE DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BIOSPHERE MEDICAL, S.A. X3180061_

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention