BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 19247495 · Received May 6, 2024

    Report

    Report Number
    3013886523-2024-00127
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    March 9, 2024
    Report Date
    July 5, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K053107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE FULL NAME OF THE REPORTING FACILITY IS (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4 (UDI# AND EXPIRATION DATE) D9, G3, G6, H2, H3, H4, H6, H11 THE SUSPECTED HAKIM VALVE (ID 823832) WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THE PRODUCT CODE 82-3832 WITH LOT 6920575 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN THE VALVE WAS RECEIVED WAS ON SETTING 80 MMH2O. UPON VISUAL INSPECTION, IT WAS NOTED THAT NEEDLE GUARD WAS DISLODGED AND THERE WAS A NEEDLE HOLE IN THE NEEDLE CHAMBER. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING AND THE TEST FAILED. THE FLUSH, PRESSURE AND LEAK TESTS COULD NOT BE PERFORMED AS THE NEEDLE GUARD WAS DISLODGED. THE VALVE WAS REFLUX TESTED, SIPHON GUARD WAS TESTED, AND BOTH PASSED. THE VALVE WAS DISASSEMBLED AND VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL AND MOTOR. A VISUAL CONTROL MAGNETIZING ENGINES WAS PERFORMED; ABNORMAL POLARIZATION WAS NOTED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE OF THE PROGRAMMING ISSUE REPORTED BY THE CUSTOMER HAS BEEN IDENTIFIED AS BIOLOGICAL DEBRIS AND PROTEIN BUILDUP INTERFERING WITH THE VALVE, AS DISCOVERED DURING THE INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ABNORMAL POLARIZATION NOTED DURING THE INVESTIGATION, COULD BE DUE TO IMPROPER USE OF MRI, AS NOTED IN THE INSTRUCTION FOR USE INSTRUCTIONS FOR USE (IFU): ANY MAGNET MAY EXPERIENCE A DEGRADATION OF MAGNETIC FIELD STRENGTH AS A CONSEQUENCE OF EXPOSURE TO THE SIGNIFICANTLY STRONGER MAGNET FIELD INDUCED IN AN MRI PROCEDURE. HOWEVER, MAGNETIC FIELDS SHOULD NOT BE PLACED NEAR THE VALVE DUE TO THE POSSIBILITY OF AN UNINTENTIONAL SETTING CHANGE. THE POSSIBLE ROOT CAUSE FOR THE NEEDLE GUARD DISLODGED, COULD BE DUE TO IMPROPER HANDLING OF THE DEVICE.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT A HAKIM VALVE/PROG VALVE INLINE W SG ((B)(6)) WAS IMPLANTED ON (B)(6) 2023. SEVERAL MONTHS LATER, THE PHYSICIAN FOUND THAT THE VALVE COULD NOT BE PROGRAMMED. ON MARCH 9, 2024, THE PHYSICIAN PERFORMED A REVISION PROCEDURE AND DISCOVERED THAT NO CEREBROSPINAL FLUID (CSF) WAS FLOWING OUT OF THE ABDOMINAL CATHETER AND SUSPECTED THAT THE VALVE WAS BLOCKED. THE PHYSICIAN RETRIEVED THE VALVE AND REPLACED IT WITH A NEW HAKIM VALVE (823832). IT WAS REPORTED THAT THE PATIENT¿S CURRENT STATUS IS STABLE. THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763249 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6920575 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Female Required Intervention