BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 19494480 · Received June 8, 2024

    Report

    Report Number
    3013886523-2024-00162
    Event Type
    Injury
    Date Received
    June 8, 2024
    Date of Event
    May 13, 2024
    Report Date
    September 13, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 823832) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD NOT BE CLEARLY DETERMINED BUT COULD BE DUE TO A TEAR/CUT IN THE SILICONE HOUSING OR A HARD KNOCK TO THE DEVICE, AS NOTED IN THE IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE. HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM AND IDENTIFY THE ROOT CAUSE OF THIS ASSUMPTION AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID (B)(6)) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR)- THE PRODUCT CODE 82-3832 WITH LOT 4203431, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 70 MMH2O. THE VALVE WAS VISUALLY INSPECTED; THE SIPHON GUARD AND CASING WERE DISLODGED. MARKS WERE NOTED ON THE SIPHON GUARD AND HOUSING. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO A TEAR/CUT IN THE SILICONE HOUSING THE DEVICE, AS NOTED IN THE INSTRUCTION FOR USE (IFU) SILICONE HAS A LOW CUT/TEAR RESISTANCE, IN VIEW OF THE MARKS ON THE DEVICE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2021. THEN THE PATIENT WAS FOUND SCALP HYDROPS AND THE PHYSICIAN SUSPECTED THAT THERE WAS CEREBROSPINAL FLUID (CSF) LEAKING. ON (B)(6) 2024, THE PHYSICIAN CONDUCTED A REVISION PROCEDURE, AND FOUND THAT THE VALVE WAS BROKEN WITH CSF LEAKING. THEN THE PHYSICIAN RETRIEVED THE DEVICE AND REPLACED WITH A NEW HAKIM (823832). AN X-RAY WAS NOT PERFORMED SINCE ALL OF THE BROKEN PARTS WERE RECOVERED. THE PATIENT IS IN STABLE CONDITION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264770 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 4203431

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention