BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 20786809 · Received November 26, 2024

    Report

    Report Number
    3013886523-2024-00375
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    November 11, 2024
    Report Date
    March 14, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519171
    PMA / PMN Number
    K053107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823114) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3114 WITH LOT 7250352, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 40 MMH2O. THE VALVE WAS VISUALLY INSPECTED; THE VALVE WAS INCLINED INSIDE OF THE SILICON CASING. THE VALVE FAILED THE TEST FOR PROGRAMMING, OCCLUSION, AND REFLUX. THE VALVE WAS LEAK TESTED AND PASSED. THE PRESSURE TEST COULD NOT BE PERFORMED AS THE DEVICE COULD NOT BE PROGRAMMED. THE VALVE WAS DISASSEMBLED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION; BIOLOGICAL DEBRIS WAS FOUND ON THE RUBY BALL, MOTOR AND ON THE SEAT OF THE RUBY BALL. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE PROGRAMMING AND OCCLUSION ISSUES ARE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE. THE POSSIBLE ROOT CAUSE FOR THE VALVE RETURNED TO THE INSIDE OF THE SILICON IS DUE TO A TOO GREAT PRESSURE AT THE MOMENT OF THE INJECTION OF LIQUID (FROM THE BIOLOGICAL DEBRIS), WHICH INFLATED THE SILICON, AND THE VALVE TURNED.

    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.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823114) IMPLANTED ON (B)(6) 2024 STOPPED DRAINING. THEREFORE THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2024. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831533 MICRO CHPV UNITIZED CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 7250352 10381780519171

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention