BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 15741421 · Received November 6, 2022

    Report

    Report Number
    3013886523-2022-00518
    Event Type
    Injury
    Date Received
    November 6, 2022
    Date of Event
    October 19, 2022
    Report Date
    December 14, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780515845
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 CERTAS VALVE (ID (B)(6)) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-8804 WITH LOT 6180895, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 4. THE VALVE WAS VISUALLY INSPECTED; THE SILICONE HOUSING WAS CUT / TORN AROUND THE SIPHON GUARD, ALSO SOME BIOLOGICAL DEBRIS WAS NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER (SILICONE HOUSING TORN), IS PROBABLE DUE TO USER¿S ERROR, AS NOTED IN THE IFU SILICONE HAS A LOW CUT/TEAR RESISTANCE. THE ROOT CAUSE FOR THE MARKS IN THE SIPHON GUARD ARE PROBABLY DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SIPHON GUARD. THE ROOT CAUSE FOR THE ¿THE VENTRICULAR ENLARGEMENT¿ ISSUE REPORTED BY THE CUSTOMER IS PROBABLY DUE TO THE CUT/TEAR IN THE SILICONE HOUSING CAUSING CSF LIQUID TO LEAK OUT INTO UNINTENTIONAL PARTS OF THE BODY.

    Description of Event or Problem · 0

    A FACILITY REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED IN A 70 YEAR-OLD FEMALE PATIENT VIA V-P SHUNT ON (B)(6) 2022 WITH UNKNOWN SETTING TO TREAT SNPH (SECONDARY NORMAL PRESSURE HYDROCEPHALUS) AFTER SAH (SUBARACHNOID HEMORRHAGE) . ON (B)(6) 2022, CSF (CEREBROSPINAL FLUID) RETENTION WAS OBSERVED UNDER THE HEAD AND ABDOMINAL SKIN, AND VENTRICULAR ENLARGEMENT WAS CONFIRMED WITHOUT ANY CLINICAL SYMPTOMS. ON (B)(6) 2022, THE VALVE WAS REMOVED AND REPLACED AS THE PATIENT WAS PRESENTING SIGNS OF DISORIENTATION AND THE VENTRICULAR ENLARGEMENT DID NOT IMPROVE. AT THE PROCEDURE, IT WAS FOUND T THAT SILICONE HOUSING OF THE VALVE WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227408 CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 10381780515845

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female