BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 21183722 · Received January 17, 2025

    Report

    Report Number
    9710358-2025-00001
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    December 5, 2024
    Report Date
    January 17, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    NAW
    UDI-DI
    00850014612146
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NON-TARGET DELIVERY OF SIR-SPHERES MICROSPHERES RESULTING IN GASTRITIS IS A RECOGNIZED POTENTIAL COMPLICATION/ADVERSE EVENT OF THIS THERAPY. A COMPREHENSIVE DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THIS PRODUCT BATCH AND DID NOT RESULT IN ANY ABNORMAL FINDINGS RELATED TO THE MANUFACTURING PROCESS. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE MALFUNCTIONED OR WAS NOT USED AS INTENDED. WE HAVE REACHED OUT TO THE TREATING PHYSICIAN FOR ADDITIONAL INFORMATION AND WILL PROVIDE AN UPDATE IF/WHEN THIS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    POST PROCEDURE IMAGING SHOWED THAT A SIGNIFICANT PORTION OF THE TREATING DOSE WAS DELIVERED TO PATIENT'S SPLEEN AND STOMACH. PATIENT EXPERIENCED NAUSEA AND PAIN AFTER THE PROCEDURE. PATIENT IS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876486 SIR-SPHERES MICROSPHERES Y90 RESIN MICROSPHERES NAW SIRTEX MEDICAL PTY LIMITED SIR-Y002 SL003 00850014612146

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female