BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRTS RA SG UTZ BAC CATH ACC

    MDR report key: 15496500 · Received September 28, 2022

    Report

    Report Number
    3013886523-2022-00444
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 11, 2022
    Report Date
    December 14, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780529286
    PMA / PMN Number
    K182265
    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

    THE CERTAS VALVE (ID 828827) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-8827 WITH LOT 6040462, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 1. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED. THE CATHETERS WERE IRRIGATED NO OCCLUSIONS NOTED. THE VALVE WAS LEAK TESTED AND NO LEAKS NOTED. 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 CAUSES FOR THE ISSUE REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO, COMPLICATION WHILE IMPLANTING THE VALVE AND/OR CATHETERS, BUT AT THE TIME OF INVESTIGATION NO FUNCTIONAL ISSUES WERE NOTED WITH THE VALVE OR CATHETERS.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS VALVE (ID 828827) RESERVOIR REMAINED DENTED. DURING THE PROCEDURE, THE VALVE WAS PLACED AND WHEN CHECKING THE WATER FLOW, THE RESERVOIR REMAINED DENTED AND DID NOT RETURN TO ITS ORIGINAL STATE. BRAIN PARENCHYMA WAS CONFIRMED IN THE VALVE, HOWEVER, THE CT CONFIRMED THAT THERE WAS NO CEREBRAL HEMORRHAGE. THEREFORE, THE VALVE WAS REMOVED AND ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY; HOWEVER, SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616299 CRTS RA SG UTZ BAC CATH ACC CERTAS PLUS SMALL & RA W/ BACTISEAL & SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 6040462 10381780529286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown