BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORLOAD

    MDR report key: 3131103 · Received May 23, 2013

    Report

    Report Number
    1225114-2013-00016
    Event Type
    Injury
    Date Received
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BIOCOMPATIBLES INC
    Product Code
    KXK
    PMA / PMN Number
    K023179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS COMPLAINT, THE PATIENT DEVELOPED STROKE-LIKE SYMPTOMS AND A CAT SCAN IDENTIFIED THAT TWO SEEDS HAD MIGRATED TO THE BRAIN. SEED MIGRATION ITSELF IS A RECOGNIZED COMPLICATION OF THE PROCEDURE INVOLVING PROSTATE BRACHYTHERAPY, HOWEVER, IT MUST BE NOTED THAT THIS ADVERSE EVENT OCCURRED WHEN THE DEVICE WAS BEING USED OUTSIDE OF THE LICENSED INDICATION FOR USE AND NO MALFUNCTION OF THE DEVICE WAS REPORTED. SINCE RECEIVING THIS REPORT THE COMPANY HAVE MADE THREE ATTEMPTS TO CONTACT THE TREATING PHYSICIAN UNSUCCESSFULLY, THEREFORE, INFORMATION REGARDING PATIENT OUTCOME IS UNAVAILABLE AT TIME OF REPORTING. CONCLUSION: THIS IS AN INTERIM COMPLAINT SUMMARY. THE SUMMARY WILL BE UPDATED AS WE RECEIVED ADDITIONAL INFORMATION FROM THE FACILITY. AT PRESENT THE CONCLUSION IS AS FOLLOWS: THE ROOT CAUSE OF THIS COMPLAINT APPEARS TO BE RELATED TO AN NON-INDICATED USE OF THE ANCHORLOAD PRODUCT.

    Description of Event or Problem · 1

    THIS IS A MEDICAL DEVICE REPORT THAT WAS REPORTED BY THE FACILITY DOSIMETRIST ON THE (B)(6) 2013. THE PATIENT (INITIALS (B)(6)) WAS TREATED FOR AN UNKNOWN INDICATION USING BIOCOMPATIBLES INC.'S ANCHORLOAD PRODUCT (ANCHORSEEDS PRE-LOADED IN SEEDLOCK3 NEEDLES). INFORMATION RELATED TO PROCEDURE AND DOSAGE WAS NOT PROVIDED; HOWEVER, THE PRODUCT ORDERED FROM (B)(4) FOR THIS IMPLANT WAS 11 SEEDLOCK3 NEEDLES PRE-LOADED WITH TWO ANCHORSEEDS EACH, SEPARATED BY A 5.5 MM SYNTHETIC SEEDING SPACER. AN ADDITIONAL FIVE SEEDS, WITHOUT ANCHORSEED ENCAPSULATION, WERE PROVIDED NON-STERILE IN A VIAL, MOST LIKELY FOR RADIOACTIVE ASSAY PURPOSES. THE REPORTER STATED THAT TREATMENT WAS A NON-INDICATED USE AND THE ANCHORLOAD PRODUCT WAS USED TO TREAT A CONDITION IN THE THROAT AREA THAT WAS LOCATED VERY CLOSE TO THE CAROTID ARTERY. IT WAS CONFIRMED THAT AN UNKNOWN TIME POST PROCEDURE THAT THE PATIENT DEVELOPED STROKE-LIKE SYMPTOMS. A CAT SCAN ON AN UNKNOWN DATE CONFIRMED MISPLACED SEALED SOURCES. THE REPORTER DESCRIBED THE DEVICE ASSOCIATION TO THE EVENT AS INDIRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230496 ANCHORLOAD SOURCE, BRACHYTHERAPY, RADIONUCLIDE KXK BIOCOMPATIBLES INC ALKIT 077047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other