BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS PLUS INLINE WITH SIPHON

    MDR report key: 13791619 · Received March 17, 2022

    Report

    Report Number
    3013886523-2022-00093
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 19, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704079040
    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 828804PL) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 4. THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLE WAS NOTED IN THE NEEDLE CHAMBER. 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. 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 ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, BUT AT THE TIME OF INVESTIGATION NO PROGRAMING ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS PLUS VALVE WAS IMPLANTED ON (B)(6) 2021 WITH SETTING 4. THE PATIENT PRESENTED WITH INCREASE IN VENTRICLE SIZE. THE PHYSICIAN TRIED TO REPROGRAM THE VALVE TO 3 WITH A ETK AND THE VALVE STAYED AT 4. AFTER MANY ATTEMPTS INCLUDING WITH THE BASIC TOOL KIT AND LOW PROFILE TOOL, THE SETTING REMAINED AT 4. THE LARGE MAGNET COULDN¿T MOVE THE SETTING OFF OF 4. X-RAY CONFIRMED SETTING IS STUCK AT 4. THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6), 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508489 CERTAS PLUS INLINE WITH SIPHON CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-8804PL 10886704079040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown