BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCALIZER

    MDR report key: 10556600 · Received September 18, 2020

    Report

    Report Number
    3013649990-2020-00003
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 18, 2020
    Manufacturer
    HEALTH BEACONS, INC.
    Product Code
    NEU
    PMA / PMN Number
    K193189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    JUSTIFICATION FOR THE SUBMISSION OF THE MDR PAST THE REQUIRED 30 DAYS: DAY 30: ON (B)(6) 2020, EMDR WAS PACKAGED FOR SUBMISSION. WHEN CONNECTED TO WEBTRADER TO SUBMIT REPORT, THE SYSTEM REJECTED THE REPORT SUBMISSION DUE TO AN EXPIRED CERTIFICATE. IT WAS NOT POSSIBLE TO RENEW THE CERTIFICATE ON 17-SEP-2020. DAY 31: ON (B)(6) 2020, AN ALTERNATE WAY TO SUBMIT THE REPORT THROUGH PARENT COMPANY (HOLOGIC INC.) WAS DECIDED UPON. REPORT IS BEING SUBMITTED ONE DAY LATE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, HEALTH BEACONS BECAME AWARE OF AN INCIDENT AT (B)(6). PATIENT WAS HAVING A HEALTH BEACONS TAG PLACED WITH A 10CM TAG APPLICATOR. ACCORDING TO THE RN, THE APPLICATOR WAS DIFFICULT TO PUSH THROUGH THE BREAST, AS THE PATIENT'S BREAST WAS VERY DENSE. AFTER EVALUATING PLACEMENT OF THE NEEDLE WITH IMAGES, THE TAG DEPLOYED AND AT SOME POINT, THE TAG APPEARS ON IMAGING TO HAVE SPLIT IN TWO PIECES. THE TAG DID NOT GIVE A SIGNAL AFTER IMPLANTATION, BUT THE SIGNAL AND TAG ID# HAD BEEN CONFIRMED DURING INTIAL SCANNING OF THE PACKAGING PRIOR TO IMPLANTATION. PATIENT BECAME VASOVAGAL DUE TO THE FACT SHE WAS SITTING UP FOR THE UPRIGHT STEREOTACTIC PLACEMENT OF THE TAG. THE PHYSICIAN DETERMINED THERE WAS ENOUGH EVIDENCE FOR ORIENTATION TO REMOVE THE AREA OF INTEREST WITHOUT DIFFICULTY, AND THE PATIENT'S SURGERY WAS SCHEDULED FOR THE FOLLOWING WEEK AS ORIGINALLY INTENDED. DATE OF THE SURGERY WAS NOT MOVED. ON (B)(6) 2020, HEALTH BEACONS SPOKE WITH THE CLINICAL SPECIALIST, WHO CONFIRMED THE REMOVAL OF THE TISSUE, AND THE TAG WERE SUCCESSFUL, AND THAT THE RECOVERED TAG HAD BEEN SENT WITH THE TISSUE TO PATHOLOGY. CLINICAL SPECIALIST EXPRESSED CONFIDENCE THAT THE CAUSE OF THE TAG BREAKAGE WAS DELIVERING THE TAG AGAINST RESISTANCE. THEY HAVE ENCOUNTERED THIS BEFORE, AND IN ANOTHER CASE HAD DETERMINED TO USE AN INTRODUCER TO AID PLACEMENT. ON 11-SEP-2020, THE FIELD REPRESENTATIVE SHARED IMAGES OF THE EXPLANTED TAG, WHICH CLEARLY SHOW THE TAG BROKEN IN TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016676 LOCALIZER TAG APPLICATOR NEU HEALTH BEACONS, INC. HB200-10 45258

    Patients

    Seq Age Sex Outcome Treatment
    1