BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORPEDO

    MDR report key: 24872967 · Received April 14, 2026

    Report

    Report Number
    9615728-2026-00069
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    April 12, 2024
    Report Date
    April 14, 2026
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    KRD
    UDI-DI
    00884450408834
    PMA / PMN Number
    K192480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THE GEL WILL NOT DEPLOY, IT GETS STUCK IN THE TORPEDO OR STUCK TO THE PUSHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151033 TORPEDO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BIOSPHERE MEDICAL, S.A. 00884450408834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown