BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 8364220 · Received February 22, 2019

    Report

    Report Number
    1226348-2019-10126
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 30, 2019
    Report Date
    January 31, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    JXG
    PMA / PMN Number
    K152152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE VALVE WAS VISUALLY INSPECTED; THE NEEDLE GUARD WAS RAISED AND BLOCKING THE FLOW. THE VALVE WAS FLUSHED; NO FLOW. THE ROOT CAUSE FOR THE RAISED NEEDLE GUARD COULD BE DUE TO HANDLING, AS NOTED IN THE IFU, DO NOT FOLD OR BEND THE VALVE, FOLDING OR BENDING MIGHT CAUSE RUPTURE OF THE SILICONE HOUSING, NEEDLE GUARD DISLODGEMENT OR OCCLUSION OF THE FLUID PATHWAY. BASED ON THE RESUTLS OF THE INVESTIGATION, THE REPORTED ISSUE WAS CONFIRMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS IMPLANTED VIA LP WITH A LUMBER CATHETER (702-JJ) AND A AND WITH ANOTHER CATHETER (82-3045) , THEN THE SYSTEM WAS CONNECTED. HOWEVER THE VALVE WAS SUSPECTED TO BE OBSTRUCTED. THEREFORE THE VALVE WAS CHANGED TO ANOTHER VALVE (NS9008) AND THE PROCEDURE COMPLETED. THE PATIENT HAS A PRIMARY DISEASE OF SUBARACHNOID HEMORRHAGE. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. THE PRODUCT WILL BE RETURNED TO YOUR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157099 CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG MEDOS INTERNATIONAL SARL 3213646

    Patients

    Seq Age Sex Outcome Treatment
    1 Other