BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING¿ INSERTION TUBE SET

    MDR report key: 20362990 · Received October 3, 2024

    Report

    Report Number
    3002250546-2024-00003
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 24, 2024
    Report Date
    October 3, 2024
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    UDI-DI
    00873263004326
    PMA / PMN Number
    K011775
    Removal / Correction Number
    3002250546-10/1/24-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INITIAL INVESTIGATION HAS FOUND THAT THE REDUCING CANNULA, INCLUDED IN THE 66-IT-05P, LOT ID: 244517 WAS BUILT USING THE WRONG DRAWING AND RESULTED IN THE CANNULA BEING 20 MM LONGER THAN SPECIFIED. THIS RESULTED IN THE REDUCING CANNULA EXTENDING DOWN 20 MM BELOW THE END OF THE INSERTION TUBE, THE TARGET LOCATION. OUR HAZARD ANALYSIS HAS DETERMINED THAT THERE IS A RISK OF HEMORRHAGE AND UNINTENDED CORING OF BRAIN TISSUE RESULTING FROM ADVANCEMENT OF A CANNULA WITH NO STYLET IN PLACE. THERE HAVE BEEN NO REPORTS OF PATIENT DEATH OR INJURY RELATED TO THIS PROBLEM. WE HAVE DETERMINED THIS TO BE A RECALL.

    Description of Event or Problem · 0

    FHC TECHNICIAN RECEIVED A CALL ON THE EVENING OF 9/24/2024 FROM DR. (B)(6) FROM (B)(6) DURING A DBS SURGERY. DR. (B)(6) WAS UNABLE TO PERFORM MER RECORDINGS WITH HIS 66-IT-05P LOT#: 244517 BECAUSE THE REDUCING CANNULA WAS MUCH TOO LONG AND EXTENDED BEYOND THE LEAD INSERTION TUBE, PREVENTING MER (THE MICROELECTRODE NEVER CAME OUT OF THE REDUCING CANNULA). THE CASE WAS DELAYED SLIGHTLY WHILE SURGEON TRIED TO FIGURE OUT WHY HE COULDN'T GET THE MER SYSTEM TO RECORD. THE SURGEON OPENED A DIFFERENT LOT OF 66-IT-05P AND WAS ABLE TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054392 MICROTARGETING¿ INSERTION TUBE SET MICROTARGETING¿ INSERTION TUBE HAW FHC, INC. 66-IT-05P-00432 244517 00873263004326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other