BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE MICRO

    MDR report key: 13942878 · Received March 29, 2022

    Report

    Report Number
    3013886523-2022-00121
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    March 10, 2022
    Report Date
    May 17, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041474
    PMA / PMN Number
    K053107
    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 HAKIM VALVE (ID 823112) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3112 WITH LOT 3285931, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; A CUT/TEAR IN THE SILICONE HOUSING AT THE PROXIMAL END WAS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK AND LEAKED FROM THE CUT/TEAR IN THE SILICONE HOUSING. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY OCCLUSIONS WITH THE VALVE AT THE TIME OF INVESTIGATION. THE ROOT CAUSE FOR THE PRESSURE ISSUE NOTED DURING THE INVESTIGATION IS DUE TO THE CUT/TEAR IN THE SILICONE HOUSING. THE ROOT CAUSE FOR THE CUT/TEAR IN THE SILICONE HOUSING IS PROBABLY DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE, AS NOTED IN THE "IFU" SILICONE HAS A LOW CUT/TEAR RESISTANCE. THE POSSIBLE ROOT CAUSE FOR THE ¿VALVE OBSTRUCTION WAS SUSPECTED¿ ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE THE CUT/TEAR IN THE SILICONE HOUSING NEAR THE PROXIMAL END.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00120. A PHYSICIAN REPORTED A CERTAS VALVE WAS IMPLANTED IN A (B)(6) YEAR-OLD FEMALE PATIENT VIA V-P SHUNT ON (B)(6) 2020 WITH SETTING 4. ON AN UNKNOWN DATE, THE PRESSURE WAS SET TO SETTING 8. ON (B)(6) 2021, THE HAKIM VALVE WAS ADDED BY CONNECTING IT WITH A Y-SHAPED CONNECTOR. THE SETTING HAS NOT BEEN CHANGED SINCE THE INITIAL PRESSURE OF 30MMH2O. SUBCUTANEOUS RETENTION OCCURRED AND VALVE OBSTRUCTION WAS SUSPECTED, THE VALVES WERE REMOVED AND REPLACED ON (B)(6) 2022.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2899234 PROG VALVE MICRO CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3112 10886704041474

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female