BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE RIGHT ANGLE

    MDR report key: 11166819 · Received January 13, 2021

    Report

    Report Number
    3013886523-2021-00015
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 10, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE WAS RETURNED FOR EVALUATION: REVIEW OF THE HISTORY DEVICE RECORDS FOR THE LOT 3841197 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS WAS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 80MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING, THE VALVE FAILED THE TEST, THE CAM MECHANISM DID NOT MOVE DURING THE PROGRAMMING PROCESS. THE VALVE FAILED THE TEST FOR REFLUX AND PRESSURE. THE VALVE WAS FLUSHED AND PASSED THE TEST. THE VALVE WAS LEAK TESTED AND NO LEAKS NOTED. THE SILICONE WAS CUT JUST AFTER VALVE CASING. THE CAM MECHANISM WAS GENTLY MOVED. THE VALVE WAS RETESTED FOR PROGRAMMING, THE VALVE FAILED THE TEST, THE CAM MECHANISM DID NOT MOVE DURING THE PROGRAMMING PROCESS. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION AND A BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE RUBY BALL, ON THE SEAT OF RUBY BALL AND ON THE CAM MECHANISM. THE CAM MAGNETS WERE CONTROLLED AND PASSED. THE ROOT CAUSE FOR THE PROGRAMING AND PRESSURE PROBLEMS NOTED DURING THE INVESTIGATION IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, AND ON THE CAM MECHANISM. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER WAS PROBABLY DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF INVESTIGATION NO OBSTRUCTION WAS NOTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    A FACILITY REPORTED AN OBSTRUCTED HAKIM VALVE: THE VALVE WAS IMPLANTED ON (B)(6) 2020. IT WAS NOTED NO IMPROVEMENT OF THE HYDROCEPHALUS; THEREFORE THE VALVE WAS EXPLANTED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61383 PROG VALVE RIGHT ANGLE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 3841197

    Patients

    Seq Age Sex Outcome Treatment
    1