BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IODINE (I-125) SEEDS IN CARRIER

    MDR report key: 4379691 · Received December 29, 2014

    Report

    Report Number
    2915056-2014-00017
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 2, 2014
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K914268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL ASSESSMENT: UNTIL THORACOTOMY AND ANATOMOPATHOLOGIC EXAMINATION HAVE BEEN PERFORMED, THE DECISION TO ADD INTRAOPERATIVE BRACHYTHERAPY TO THE TREATMENT REGIMEN CANNOT BE CLARIFIED. IN THE CASE OF A BRACHYTHERAPY IMPLANT BEING INDICATED, THE IMPLANT IS CONSTRUCTED IN SITU IN THE OPERATING THEATRE AND IMPLANTED VIA THE THORACOTOMY SURGICAL ACCESS. THE PRODUCT IS MOST LIKELY NOT UNPACKED OR OPENED PRIOR TO THE SURGICAL ACT AS IT IS NOT KNOWN IF IT IS GOING TO BE REQUIRED UNTIL THE RESULTS OF THE FROZEN SECTION ARE AVAILABLE. THUS IF THE SEEDS ARE MISSING FROM A STRAND, THERE MAY BE NO WAY TO COMPENSATE FOR THE SHORTFALL AND THEREFORE THE DOSE TO THE TUMOR BED MAY NOT BE SUFFICIENT TO CONTRIBUTE TO LOCAL CONTROL IN THE MANNER PLANNED BY THE SURGEON AND RADIATION ONCOLOGIST. HOSPITALS WILL OFTEN ORDER MORE SEEDS THAN ARE LIKELY TO BE REQUIRED AND THERE IS SOME LEEWAY WITH REGARD TO THE PLANNING AND PLACEMENT OF THE PLANAR IMPLANT AS SEEN IN THIS CASE. CONCLUSION: DUE TO THE "LAST MINUTE" AND UNPREDICTABLE USE OF SEEDS IN THIS PROCEDURE WHICH CANNOT BE FORESEEN PRIOR TO COMMENCEMENT OF SURGERY, ABSENCE OF SEEDS IN THE SEED IN CARRIER PRODUCT COULD CAUSE LOWER THAN PLANNED DOSE OF THE INTERSTITIAL IMPLANT. THIS MAY IMPACT THE EFFECT ON LOCAL CONTROL OF NON-SMALL CELL LUNG CANCER.

    Description of Event or Problem · 1

    ON (B)(6) 2014, GE HEALTHCARE RECEIVED INFORMATION CONCERNING A DEVICE MALFUNCTION WITH NO ASSOCIATED ADVERSE EVENT. AN ORDER OF 4 SEEDS IN CARRIER WAS SENT TO THE CUSTOMER WITH ONE CARRIER WITH SEEDS MISSING. ON (B)(6) 2014, IT WAS REPORTED THAT THE CUSTOMER RECEIVED THEIR ORDER FOR 4 SEEDS IN CARRIER (BATCH NUMBER C14015B) AND NOTICED IN OR /SURGERY THAT ONE OF THE CARRIERS HAD NO SEEDS IN IT. AN EMPTY SUTURE WAS LOADED INTO THE RING. CUSTOMER PERFORMED GEIGER SURVEY TO ENSURE SHE WASN'T MISSING ANYTHING. MARGIN PATHOLOGY WAS POSITIVE SO ADJUVANT SEED THERAPY WAS ESSENTIAL. THE THORACIC SURGEON IS A PREMIER CLINICIAN, AFTER PHYSICS WORKED TO RE-CALCULATE DOSING AND RE-SPACE THE REMAINING STRANDS ON THE MESH, HE WAS CONFIDENT THAT THEY WERE ABLE TO DIRECT PLACEMENT TO ACHIEVE AN EFFECTIVE TREATMENT DOSE. ON (B)(6) 2014, THE CUSTOMER CONFIRMED THAT THE EMPTY CARRIER AND THE SUTURE WERE DISPOSED OF AN ARE NOT AVAILABLE FOR INVESTIGATION. THIS MALFUNCTION WAS ASSESSED AS HAVING THE POTENTIAL TO CAUSE DEATH OR SERIOUS INJURY SHOULD IT RECUR. QUALITY ASSURANCE INVESTIGATION INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855580 IODINE (I-125) SEEDS IN CARRIER RADIONUCLIDE BRACHYTHERAPY SOURCE KXK GE HEALTHCARE 6720 C14015B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other