BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 18945390 · Received March 20, 2024

    Report

    Report Number
    3013886523-2024-00079
    Event Type
    Injury
    Date Received
    March 20, 2024
    Report Date
    July 11, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041467
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (UNITIZED), WAS RETURNED FOR EVALUATION WITHOUT THE CATHETER. DHR - LOT 153061, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; THE NEEDLE GUARD PART OF THE VALVE HAS BEEN CUT AWAY AND NOT RETURNED, TIE MARKS WERE NOTED IN THE PROXIMAL END OF THE VALVE, A CUT IN THE SILICONE HOUSING ALONG THE VALVE CASING WAS ALSO NOTED. THE BIOLOGICAL DEBRIS WERE NOTED INSIDE THE HOUSING. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, REFLUX AND PRESSURE. THE VALVE WAS LEAK TESTED; ONLY LEAK FROM CUT. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED AS THE CATHETER WAS NOT RETURNED FOR INVESTIGATION. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO AN ISSUE AT IMPLANTATION PHASE (CATHETER TOO SHORT / CATHETER DAMAGED FOR EXAMPLE). THE ROOT CAUSE FOR THE CUT/TEAR IN THE SILICONE HOUSING ALONG THE VALVE CASING" 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.

    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.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2024-00078. A FACILITY REPORTED A PATIENT PRESENTED WITH HYDROCEPHALUS SYMPTOMS. A X-RAY WAS TAKEN ON (B)(6) 2024 SHOWING A BROKEN CATHETER. THE CATHETER AND THE HAKIM VALVE WERE EXPLANTED DUE TO BROKEN CATHETER. THE VALVE WAS IMPLANTED IN 2018 AND THE CATHETER IN 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892270 HAKIM PROGRAMMABLE VALVE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 10886704041467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown