BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCOUT DELIVERY NEEDLE AND REFLECTOR

    MDR report key: 14438454 · Received May 19, 2022

    Report

    Report Number
    2032338-2022-00002
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 6, 2022
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    NEU
    UDI-DI
    00852205006024
    PMA / PMN Number
    K141318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT REFLECTOR IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. 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. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    "THE REPORTER ALLEGES THAT DURING AN EXCISIONAL BIOPSY PROCEDURE, THE ATTENDING PHYSICIAN WAS ADVISED OF A REFLECTOR'S LOCATION BY THE RADIOLOGIST. PRIOR TO PREPPING THE PATIENT, THE PHYSICIAN SURVEYED THE BREAST WITH A BACKUP GUIDE IN ATTEMPTS TO LOCATE THE REFLECTOR. SEVERAL BEEPS WERE RECEIVED REPEATEDLY. THE PHYSICIAN USED AN ULTRASOUND PROBE TO TRY AND LOCATE THE REFLECTOR BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO MAKE AN INCISION. THE GUIDE WAS PLACED WITHIN THE PATIENT'S BREAST, NO SIGNAL COULD BE HEARD. MOVING THE GUIDE AROUND, THE PHYSICIAN WAS EVENTUALLY ABLE TO HEAR A CADENCE, ON THE LEFT BREAST AT THE LOWER INNER QUADRANT. THE PHYSICIAN BEGAN FORMING A LARGE BALL WITH THE CUTTING BOVIE TO ENSURE THAT THE REFLECTOR WOULD BE REMOVED WITH THE SPECIMEN. ONCE THE SPECIMEN WAS OUT OF THE BODY, A CADENCE WAS HEARD. THE PHYSICIAN PLACED THE GUIDE BACK IN THE PATIENT AND HEARD A CADENCE IN A POSITION WHERE THERE WAS NO LONGER ANY BREAST TISSUE. THE PHYSICIAN REMOVED ANOTHER SPECIMEN FROM THE PATIENT BUT COULD NOT LOCATE THE REFLECTOR. THE PHYSICIAN PUT THE GUIDE BACK IN THE CAVITY WHERE THE SPECIMEN CAME OUT AND HEARD A STEADY CONSISTENT CADENCE. THE PHYSICIAN PLACED THE GUIDE ON THE OPPOSITE SIDE OF THE BREAST AND RECEIVED A STEADY CADENCE. THE PHYSICIAN WENT BACK TO THE PATIENT AND CUT OUT ANOTHER VERY SMALL SPECIMEN. AFTER THE SPECIMEN WAS REMOVED. AGAIN, THE PHYSICIAN COULD NOT LOCATE THE REFLECTOR WITH THE GUIDE. THERE WERE MULTIPLE OCCASIONS WHERE THE CADENCE AND DEPTH DID NOT LEAD TO WHERE THE REFLECTOR WAS LOCATED. THE PHYSICIAN WAS CONCERNED THAT A PATIENT ENDED UP WITH A PARTIAL MASTECTOMY WHILE SEARCHING FOR A REFLECTOR. THE PROCEDURE WAS COMPLETED WITHOUT LOCATING THE REFLECTOR. THE GUIDE USED FOR THIS PROCEDURE WAS RELIABLE. WHEN THE GUIDE WAS NOT IN USE, THERE WAS NO INTERFERENCE. THE PATIENT DID NOT HAVE ANYTHING ON THEM THAT COULD HAVE INTERFERED WITH THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293949 SCOUT DELIVERY NEEDLE AND REFLECTOR INTERNAL TISSUE MARKER NEU MERIT MEDICAL SYSTEMS INC. SSR75-01 00852205006024

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability