BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOAID ADVANTAGE STRAND

    MDR report key: 5735349 · Received June 20, 2016

    Report

    Report Number
    3003440305-2016-00001
    Event Type
    Malfunction
    Date Received
    June 20, 2016
    Report Date
    June 14, 2016
    Manufacturer
    ISOAID LLC
    Product Code
    KXK
    PMA / PMN Number
    K091117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY ISOAID REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    TWO BRACHYTHERAPY NEEDLES (NEEDLES 2 AND 15) FAILED TO DEPLOY DURING THE BRACHYTHERAPY IMPLANT PROCEDURE. THE ORDER TOTALED 20 ADVANTAGE STRANDS WITH 67 SEEDS; THE TOTAL SEEDS WHICH WERE NOT DELIVERED WAS NINE. THE PATIENT WAS PLANNED TO RECEIVE 100% OF THE DOSE TO 43 CC. DUE TO THE INABILITY TO IMPLANT THE TWO STRANDS CONTAINING 9 SEEDS, THE INITIAL IMPLANT COVERED 39.28 CC WITH 100% OF THE DOSE. THE PATIENT WAS SENT HOME AND RESCHEDULED TO RECEIVE A SECOND IMPLANT PROCEDURE. AN ADDITIONAL 20 SEEDS WERE ORDERED BY AND SUPPLIED TO THE USER FACILITY AND THE RESCHEDULED PROCEDURE OCCURRED NINE DAYS AFTER (B)(6). THE SECOND PROCEDURE WAS PERFORMED TO COMPLETE THE ORIGINAL TREATMENT DOSE PRESCRIPTION. THE TREATMENT EFFICACY WAS DELAYED SINCE THE PATIENT WAS SUBJECTED TO A SECOND PROCEDURE TO ASSURE A CORRECT TREATMENT DOSE. A QUALITY ASSURANCE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390617 ISOAID ADVANTAGE STRAND BRACHYTHERAPY SEEDS AND STRAND KXK ISOAID LLC 201641966

    Patients

    Seq Age Sex Outcome Treatment
    1