BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEEDSELECTRON, FIRST SYSTEM

    MDR report key: 1370315 · Received February 27, 2009

    Report

    Report Number
    9611894-2009-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2009
    Date of Event
    February 16, 2009
    Report Date
    February 26, 2009
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    PMA / PMN Number
    K010032
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE DELIVERY TUBE COMPONENT THERE IS FLANGE WHICH IS FIXATED TO THE DELIVERY TUBE VIA A CRIMP. UPON INVESTIGATION, THE CRIMP WAS FOUND INCOMPLETE. AS A RESULT, THE FLANGE WAS DISPLACED AND PREVENTED PROPER NEEDLE RETRACTION WHICH PREVENTED PROPER PLACEMENT OF THE I-125 SEEDS. THIS IS THE FIRST NOTED OCCURRENCE OUT OF 9000 UNITS. ALL UNITS IN STOCK WERE INSPECTED. THEY WERE ADEQUATE.

    Description of Event or Problem · 1

    A PT WAS UNDERGOING A PROSTATE SEED IMPLANT IN (B) (6) USING WITH SEEDSELECTRON. THE TREATMENT INTENDED TO IMPLANT (51) I-125 SEEDS. THERE WAS A PROBLEM WITH THE DELIVERY TUBE THROUGH WHICH THE SEEDS ARE PLACED IN THE PROSTATE, AS A RESULT, 31 SEEDS WERE PLACED CORRECTLY, 14 SEEDS STAYED IN THE NEEDLES; 4 SEEDS STAYED IN THE BASE PLANE; 2 SEEDS STAYED IN THE PERINEUM. MANUAL METHODS WERE USED TO IMPLANT 18 OF THE 20 SEEDS NOT DELIVERED BY THE SEEDSELECTRON DEVICE. THE 2 SEEDS IN THE PERINEUM COULD NOT BE REMOVED. AS SUCH THE PERINEUM RECEIVED AN UNINTENDED DOSE OF RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEEDSELECTRON, FIRST SYSTEM REMOTE CONTROLLED AFTERLOADER JAQ NUCLETRON B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1