BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 22097435 · Received May 28, 2025

    Report

    Report Number
    3013886523-2025-00120
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    July 11, 2022
    Report Date
    October 31, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041498
    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823114) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT IS NOT AVAILABLE FOR RETURN AS PER CUSTOMER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, BASED ON THE REPORTED INCIDENT, THE PROBABLE ROOT CAUSE OF THIS ISSUE COULD BE RELATED TO BIOLOGICAL DEBRIS AND PROTEIN BUILDUP INTERFERING WITH AND BLOCKING THE CATHETER. 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

    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

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00121. EVENT REPORTED FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A PATIENT HAD SEVERE DILATION AND HYDROCEPHALUS OF THE LEFT SUPRATENTORIAL VENTRICLE IN (B)(6) 2021. DURING AN EXAMINATION ON (B)(6) 2022, AN INCREASE IN HYDROCEPHALUS WAS FOUND; THEREFORE, A HAKIM VALVE (ID 823114) AND A BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2022. IN (B)(6) 2022, DURING A FOLLOW-UP VISIT, IT WAS FOUND THAT THE HYDROCEPHALUS HAD INCREASED AND THE CATHETER WAS BLOCKED. THE PATIENT HAD V-P SHUNT SURGERY AND CATHETER REPLACEMENT. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357937 MICRO CHPV UNITIZED CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 3908895 10886704041498

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Female Required Intervention