BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ

    MDR report key: 12082660 · Received June 29, 2021

    Report

    Report Number
    1018233-2021-03872
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 14, 2021
    Product Code
    KXK
    PMA / PMN Number
    K093663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBERS OF THE SEEDS AND THE LOT NUMBER OF THE CARTRIDGE. THESE LOTS MET ALL RELEASE CRITERIA. HOWEVER, THIS PRODUCT CODE IS NOT DESIGNATED WITH A LOT NUMBER, THIS INFORMATION IS NOT APPLICABLE FOR THE HISTORY REVIEW. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED ISSUE. BASED UPON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. LABELING REVIEW: THE INFORMATION FOR USE WAS REVIEWED FOR QUICKLINK DELIVERY SYSTEM. THERE IS A CAUTION STATEMENT, WHICH STATES "IN THE EVENT THE QUICKLINK¿ LOADER OR CARTRIDGES BECOME INOPERABLE DUE TO DAMAGE OR MALFUNCTION, ANY OR ALL COMPONENTS MAY BE REMOVED FROM THE CARTRIDGES AND IMPLANTED MANUALLY." THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE BRACHYSOURCE I-125 SEEDS IN QUICKLINK CARTRIDGE SINGLE, STERILE PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE BRACHYSOURCE I-125 SEEDS IN QUICKLINK CARTRIDGE SINGLE, STERILE PRODUCTS ARE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE LAST SEED ALLEGEDLY WOULD NOT EJECT PROPERLY. IT WAS FURTHER REPORTED THAT A SIMILAR EVENT OCCURRED WITH THREE CARTRIDGES. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982403 I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ BRACHYTHERAPY LINKS AND CARTRIDGES KXK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other