BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 21773362 · Received April 4, 2025

    Report

    Report Number
    3013886523-2025-00070
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 15, 2025
    Report Date
    July 25, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K221840
    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.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823832) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3832 WITH LOT 7302945 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT 60 MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFAULTS WERE OBSERVED. THE VALVE WAS HYDRATED. THE FAILED THE TEST FOR PROGRAMMING: THE CAM MECHANISM WIGGLED. THE VALVE PASSED THE TEST FOR OCCLUSION, LEAK, REFLUX AND SIPHON GUARD. THE PRESSURE TEST COULD NOT BE PERFORMED BECAUSE THE DEVICE COULD NOT BE PROGRAMMED. THE VALVE WAS DISASSEMBLED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION; BIOLOGICAL DEBRIS WERE FOUND ON THE SEAT OF THE RUBY BALL AND MOTOR. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE IN VIEW OF THE BIOLOGICAL DEBRIS FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2025. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) CHECK ON (B)(6) 2025, AND THE VALVE WAS AT THE PROPER POSITION. ON (B)(6) 2025, THE PATIENT WAS FOUND WITH UNDERDRAINAGE AND THE VENTRICLE WAS ENLARGED. THEREFORE, THE VALVE WAS REMOVED AND REPLACED. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686623 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 7302945 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention