BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRTS SM IL VLV UTZ CATH ACC

    MDR report key: 15156433 · Received August 3, 2022

    Report

    Report Number
    3013886523-2022-00362
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 4, 2022
    Report Date
    September 7, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780529347
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CERTAS VALVE WAS RETURNED FOR EVALUATION: DHR LOT 5103370, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS : THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: - INCREASE OF SURGERY TIME OF 15 MINUTES - DEVICE WAS TESTED FOR SETTING BEFORE IMPLANTATION - NO CONSEQUENCE FOR PATIENT.

    Description of Event or Problem · 0

    A FACILITY REPORTED A CERTAS PLUS SMALL VALVE DID NOT FUNCTION EVEN IF ALL THE ELEMENTS WERE CORRECTLY IMPLANTED (CORRECT PLACE) WITHOUT BENDING (VENTRICULAR CATHETER ,VALVE ,DISTAL CATHETER). THE DEVICE WAS REPLACED DURING PROCEDURE.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583466 CRTS SM IL VLV UTZ CATH ACC CERTAS PLUS SMALL & RA JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 5103370 10381780529347

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown