BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD BRACHYTHERAPHY IODINE 125 SEED

    MDR report key: 693061 · Received March 27, 2006

    Report

    Report Number
    1018233-2006-00054
    Event Type
    Injury
    Date Received
    March 27, 2006
    Date of Event
    February 21, 2006
    Report Date
    March 22, 2006
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KXK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AN IODINE SEED RUPTURED DURING A BRACHYTHERAPY SEED IMPLANT PROCEDURE. FOLLOW-UP WITH THE NUCLEAR MEDICINE TECHNICIAN REVEALED THAT THE APPLICATOR JAMMED DURING THE IMPLANT AND THE RADIATION ONCOLOGIST FORCEFULLY REMOVED THE CARTRIDGE FROM THE APPLICATOR. AFTER REMOVING THE CARTRIDGE, A SEED WAS FOUND STILL IN THE APPLICATOR AND THE DOCTOR FORCIBLY REMOVED IT. THE REMOVAL PROCESS COMPROMISED THE SEED AND RESULTED IN THE APPLICATOR BECOMING CONTAMINATED. FOLLOWING THE IMPLANT, REMOVABLE CONTAMINATION WAS FOUND ON THE APPLICATOR AND THE GENERAL WORK AREA. ALSO, FOLLOWING A CYSTOSCOPY, THE PATIENT'S BLADDER WAS FLUSHED AND METALLIC PIECES WERE FOUND IN THE FLUSHED URINE. THE URINE WAS SURVEYED AND FOUND TO BE RADIOACTIVE. SEVERAL DAYS LATER, A BIOASSAY WAS PERFORMED ON THE PATIENT AND THERE WAS A SMALL UPTAKE IN THE PATIENT'S THYROID LESS THAN 1 CGY (REM). THIS DOSE FALLS SHORT OF A MEDICAL EVENT AS OUTLINED IN 10CFR PART 35.3045 (A) (1). THE PATIENT WAS PRESCRIBED POTASSIUM IODINE AS A THYROID BLOCKER AND WILL REMAIN ON THIS FOR TEN DAYS. THE DOCTOR COULD FIND NO IODINE -125 REMAINING IN PATIENT'S URINE INDICATING CONTAMINATION CAME FROM THE RECOVERED COMPROMISED SEED AND NOT FROM AN IMPLANTED SEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD BRACHYTHERAPHY IODINE 125 SEED IODINE SEED KXK C.R. BARD, INC. NA PSL67199

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN