BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 16684111 · Received April 5, 2023

    Report

    Report Number
    3013886523-2023-00099
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    February 25, 2023
    Report Date
    June 3, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K053107
    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 WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAKS, REFLUX AND PRESSURE. THE CATHETER WAS IRRIGATED NO OCCLUSIONS NOTED. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED FOR THE ISSUE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF INVESTIGATION NO OCCLUSION ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823114) WAS IMPLANTED ON (B)(6) 2022, AND ON (B)(6) 2023 WAS EXPLANTED DUE TO BLOCKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348652 MICRO CHPV UNITIZED CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 4643991

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown