BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGTRACE AND SENTIMAG MAGNETIC LOCALIZATION SYSTEM

    MDR report key: 24873190 · Received April 14, 2026

    Report

    Report Number
    3012644426-2026-00001
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ENDOMAGNETICS LTD
    Product Code
    PUV
    UDI-DI
    15060391210244
    PMA / PMN Number
    P160053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE DEVICE'S SINGLE USE NATURE, IT WAS DISCARDED AND COULD NOT BE TESTED. ROOT CAUSE CANNOT BE DETERMINED. HYPERSENSITIVITY TO AN IRON OXIDE OR DEXTRAN COMPONENT OF MAGTRACE IS SUSPECTED; ALLERGY WAS NOT TESTED PRE PROCEDURE. COMPLAINT RECORDS AND BMR FOR THE LOT WERE REVIEWED; NO RELATED TRENDS OR ADDITIONAL COMPLAINTS IDENTIFIED. PATHOLOGY RESULTS PENDING.

    Description of Event or Problem · 0

    AN 80-YEAR-OLD MALE PATIENT WITH A DIAGNOSIS OF BREAST CANCER WAS SCHEDULED FOR SURGERY WITH INDICATION FOR SENTINEL LYMPH NODE BIOPSY (SLNB), (INVASIVE DUCTAL CARCINOMA, LUMINAL A). ONE WEEK PRIOR TO SURGERY, THE SURGEON ADMINISTERED 2ML OF MAGTRACE FOLLOWING THE STANDARD PROCEDURE IN THE IFU. SHORTLY AFTER THE INJECTION, THE PATIENT REPORTED THE APPEARANCE OF A SKIN REACTION/RASH AT THE INJECTION SITE. BURNING/ITCHING IS NOTED IN THE SKIN IN THE BREAST AREA AS WELL AS IN THE AXILLA. (MT, LIKELY CORRESPONDING TO THE PECTORALIS MAJOR REGION). ON THE DAY OF THE SURGERY, THIS LESION WAS OBSERVED IN THE OPERATING ROOM. THE SURGEON INITIALLY SUSPECTED A TUMOR. HOWEVER, THE PATIENT STATED THAT THE LESION HAD DEVELOPED AFTER THE INJECTION. THE INITIAL PLAN WAS TO PERFORM A LOCAL EXCISION OF THE LESION AND SEND AN INTRA-OPERATIVE BIOPSY TO THE PATHOLOGY DEPARTMENT (ANATOMICAL PATHOLOGY) FOR ANALYSIS. HOWEVER, THE SURGICAL APPROACH WAS ULTIMATELY CHANGED, AND A TOTAL MASTECTOMY WAS PERFORMED. THE ENTIRE BREAST TISSUE WAS SENT FOR PATHOLOGICAL EVALUATION. RESULT ARE CURRENTLY PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931028 MAGTRACE AND SENTIMAG MAGNETIC LOCALIZATION SYSTEM MAGTRACE PUV ENDOMAGNETICS LTD MTVC10 1114PP190 15060391210244

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other