BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 17483175 · Received August 8, 2023

    Report

    Report Number
    3013886523-2023-00257
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    July 22, 2023
    Report Date
    October 13, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K053107
    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

    THE HAKIM VALVE (ID 823832) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-3832 WITH LOT 6467404, CONFORMED TO THE SPECIFICATIONS WHEN RELEASE. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED: LIQUID BIOLOGICAL DEBRIS WAS NOTED INSIDE THE VALVE MECHANISM. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 100MMH2O. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED FOR THE FAILURE ISSUE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. HOWEVER, THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, AS SEEN IN THE INVESTIGATION REPORT NO PROGRAMING ISSUES WERE NOTED DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, THE VALVE COULD NOT BE PROGRAMMED AND THE PATIENT UNDERGONE REVISION PROCEDURE. THEREFORE, THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2023. AT THE PROCEDURE, THE CATHETER AND THE VALVE RETRIEVED WERE FOUND OCCLUDED. THE PATIENT DID NOT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929532 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6467404 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown