BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRTS RA VLV ONLY

    MDR report key: 17906715 · Received October 10, 2023

    Report

    Report Number
    3013886523-2023-00349
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 21, 2023
    Report Date
    January 5, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Product Problem
    Yes
    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

    UPDATED FIELDS: D1, D2A, D4, D9, G3, G6, H2, H3, H4, H6, H10. THE CERTAS VALVE (ID 828820) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-8820 WITH LOT 4951887, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 4. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX AND PRESSURE. THE VALVE WAS LEAK TESTED; NO LEAKS NOTED. ROOT CAUSE ANALYSIS ¿ NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. HOWEVER, A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BAD POSITION OR ALIGNMENT OF PATIENT FOR ADEQUATE PLACEMENT OF VALVE. AS NOTED IN THE INVESTIGATION REPORT, NO FLOW ISSUES WERE NOTED WITH THE VALVE.

    Description of Event or Problem · 0

    THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00350. 3013886523-2023-00351. A PHYSICIAN REPORTED THAT DURING SURGERY, CEREBROSPINAL FLUID FLOW WAS CONFIRMED WHEN THE VENTRICULAR CATHETER WAS INSERTED. HOWEVER, NO CEREBROSPINAL FLUID FLOW WAS OBSERVED AFTER THE CERTAS VALVE (828800), BACTISEAL PERITONEAL CATHETER (823074), AND BACTISEAL VENTRICULAR CATHETER (823073) WERE CONNECTED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED AND THE EVENT LED TO MORE THAN 30 MINUTES SURGICAL DELAY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291376 CRTS RA VLV ONLY CERTAS PLUS SMALL & RA JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4951887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BACTISEAL PERITONEAL CATHETER ID 823074| BACTISEAL VENTRICULAR CATHETER ID823073