BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLINE VLV W/ SPHNGRD

    MDR report key: 13170952 · Received January 5, 2022

    Report

    Report Number
    3013886523-2021-00579
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    September 8, 2021
    Report Date
    February 23, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    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 WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 828805 WITH LOT 5191467 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 8. THE VALVE WAS VISUALLY INSPECTED, THE SILICON HOUSING WAS TORN/CUT AROUND THE SIPHON GUARD AND NEEDLE HOLES WERE NOTED IN THE NEEDLE CHAMBER. THE VALVE WAS HYDRATED. THE CATHETERS WERE IRRIGATED NO OCCLUSIONS NOTED. THE VALVE WAS LEAK TESTED: LEAKED FROM THE CUT/TEAR IN THE SILICONE HOUSING AROUND THE SIPHON GUARD. THE VALVE COULD NOT BE REFLUX TESTED DUE TO THE DAMAGED SILICONE HOUSING. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, SIPHON GUARD AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED FOR THE OVER DRAINAGE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY PRESSURE ISSUES WITH THE VALVE AT THE TIME OF INVESTIGATION. THE ROOT CAUSE FOR THE CUT/TEAR IN THE SILICONE HOUSING AS NOTED IN THE COMPLAINT THIS WAS DONE WHEN REMOVING THE VALVE. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, BUT AT THE TIME OF INVESTIGATION NO OVER DRAINAGE ISSUES WERE NOTED. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER ¿IT WAS REMOVED DUE TO INFECTION¿ COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS VALVE ((B)(4)) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2021 WITH SETTING 4. DUE TO THE TENDENCY OF OVER DRAINAGE, THE SET PRESSURE OF THE VALVE WAS RAISED TO 5 AND 7 AND THERE WAS NO CHANGE IN THE SIZE OF THE VENTRICLES WHEN THE PRESSURE WAS CHANGED. THE VALVE WAS REMOVED ON (B)(6) 2021 DUE TO INFECTION AND WAS FOUND TO BE DAMAGED. IT IS UNKNOWN THE TYPE OF INFECTION/ORGANISM AND WHICH TESTS WERE DONE TO CONFIRM THE INFECTION. IT IS ALSO UNKNOWN WHICH TREATMENT/MEDICATION WAS GIVEN FOR THE INFECTION. THE PATIENT IS IN THE FOLLOW UP.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616941 CERTAS INLINE VLV W/ SPHNGRD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 5191467

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female