BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSPERA PD -103 BRACHYTHERAPY SOURCE

    MDR report key: 1101768 · Received July 24, 2008

    Report

    Report Number
    2915056-2008-00004
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    NORTH AMERICAN SCIENTIFIC
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF BATCH RECORDS SHOWED NO DEVIATIONS. REVIEW OF PRODUCT COMPLAINT RECORDS SHOWED NO OTHER INSTANCES OF NEEDLES BENDING OR BREAKING. THE NEEDLE IS DESIGNED FOR INSERTION OF BRACHYTHERAPY SOURCES INTO SOFT TISSUE AND NOT FOR BONE PENETRATION, AND IT WAS CONCLUDED THAT USER ERROR CAUSED THE MALFUNCTION.

    Description of Event or Problem · 1

    IN 2008, A MALE PT UNDERWENT IMPLANTATION OF PALLADIUM-103 SEEDS (ONCURA MODEL MED3633 LOADED INTO CP MEDICAL NEEDLES) FOR PROSTATE CANCER BRACHYTHERAPY. ON INSERTION OF THE FIRST NEEDLE, WHICH WAS LOADED WITH 5 PD-103 SEEDS, THE BONE WAS IMPACTED. THE NEEDLE WAS WITHDRAWN AND WAS FOUND TO BE BENT APPROXIMATELY 8CM FROM THE TIP, WITH 3CM DANGLING FROM THE POINT AT WHICH IT WAS BENT, AND A 5CM LENGTH REMAINING INSIDE THE PT. ALL THE SEEDS WERE WITHDRAWN WITH THE BENT NEEDLE, 3 WITHIN THE BENT PORTION AND 2 EXPOSED. THE 5CM LENGTH WAS SURGICALLY REMOVED FROM THE PT, THE INCISION CLOSED WITH TWO SUTURES, AND THE IMPLANTATION CONTINUED ACCORDING TO STANDARD PROCEDURE. THE SEEDS FROM THE BROKEN NEEDLE WERE SECURED IN A LEAD-SHIELDED CONTAINER (TO WHICH 3 UNUSED SEEDS WERE LATER ADDED) AND HANDLED ACCORDING TO STANDARD PROCEDURES FOR RETURN TO THE VENDOR. ENVIRONMENTAL SURVEY SHOWED BACKGROUND LEVELS OF RADIATION AND RADIOGRAPHY OF THE PT SHOWED NORMAL DISTRIBUTION OF THE IMPLANTED SEEDS. EVALUATION WAS CONDUCTED BY THE MFR OF THE NEEDLE. REVIEW OF BATCH RECORDS SHOWED NO DEVIATIONS. REVIEW OF PRODUCT COMPLAINT RECORDS SHOWED NO OTHER INSTANCES OF NEEDLES BENDING OR BREAKING. THE NEEDLE IS DESIGNED FOR INSERTION OF BRACHYTHERAPY SOURCES INTO SOFT TISSUE AND NOT FOR BONE PENETRATION, AND IT WAS CONCLUDED THAT USER ERROR CAUSED THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSPERA PD -103 BRACHYTHERAPY SOURCE BRACHYTHERAPY IMPLANT KXK NORTH AMERICAN SCIENTIFIC MED3633 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1