BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLIN VLV ONLY W/ SPHNGD

    MDR report key: 3790011 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11523
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS RETURNED FOR EVALUATION AT CODMAN (B)(4). THE INVESTIGATION OF THE RETURNED VALVE DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER WAS CNMCDV, PRODUCT CODE 82-8804. UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE NO ROOT CAUSE COULD BE DETERMINED AS NO PROBLEM WAS FOUND WITH THE VALVE. THE PROBLEM WAS LIKELY 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. BASED ON THE INVESTIGATION THIS COMPLAINT IS CONSIDERED CLOSED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "I HAVE A MALFUNCTIONING CERTAS VALVE. SURGEON ENDED UP USING STRATA VALVE. IT IS ON MY DESK". FURTHER INFORMATION INDICATED "CERTAS VALVE MALFUNCTIONED AND DID NOT WORK AS EXPECTED". (B)(4) ADDITIONAL INFORMATION EXPLAINED THAT PRIMING WAS BEING CONDUCTED DURING AN INTRA OPERATIVE PROCEDURE AND IT WAS NOTED THAT THE DEVICE WAS OCCLUDED. SURGEON USED A COMPETITOR PRODUCT. NO DELAY IN SURGERY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268933 CERTAS INLIN VLV ONLY W/ SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CNMCDV

    Patients

    Seq Age Sex Outcome Treatment
    1