BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 14146184 · Received April 19, 2022

    Report

    Report Number
    3013886523-2022-00169
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 31, 2022
    Report Date
    July 5, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K053107
    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

    THE HAKIM VALVE (ID 823832) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3832 WITH LOT 5321744, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 150MMH2O. THE VALVE WAS HYDRATED. THE CATHETER WAS IRRIGATED NO OCCLUSIONS NOTED. THE VALVE WAS LEAK TESTED AND NO LEAKS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD 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 PROBLEM REPORTED BY THE CUSTOMER COULD BE DUE TO AN EXCESSIVE FLOW RATE (>0.75 ML/MIN) DURING THE FLUSHING PROCEDURE ACTIVATES THE SIPHON GUARD AND CREATES THE IMPRESSION THAT THE VALVE IS DISTALLY OCCLUDED. IN REALITY THE FLOW IS BEING DIVERTED TO THE HIGH RESISTANCE SECONDARY PATHWAY, THIS WILL SLOW THE RATE AT WHICH CSF IS SHUNTED FROM THE BRAIN. IT WOULD PROBABLY EXPLAIN THE PROBLEM ENCOUNTERED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: ISSUE DETECTED AFTER IMPLANTATION DURING PROCEDURE. IT IS UNKNOWN IF THE EVENT LED TO SURGICAL DELAY.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823832) DID NOT DRAIN DURING PROCEDURE AND AND WAS REPLACED. THE PHYSICIAN INFORMED THAT THE VALVE WAS COLLAPSING IN THE CEREBROSPINAL FLUID CHAMBER. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987189 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 823832 5321744 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown