BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE RIGHT ANGLE

    MDR report key: 11165145 · Received January 13, 2021

    Report

    Report Number
    3013886523-2021-00017
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    October 20, 2020
    Report Date
    March 16, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - LOT 3841197, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, SOME BIOLOGICAL DEBRIS WAS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 100MMH2O. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, LEAKS, OCCLUSION, REFLUX AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF THE INVESTIGATION NO OCCLUSION ISSUES WERE 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 A HAKIM VALVE WAS FOUND OBSTRUCTED DURING IMPLANTATION PROCEDURE. IT WAS REPLACED WITH A NEW VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62743 PROG VALVE RIGHT ANGLE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4335187

    Patients

    Seq Age Sex Outcome Treatment
    1