BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 13652808 · Received March 2, 2022

    Report

    Report Number
    3013886523-2022-00071
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    January 20, 2022
    Report Date
    April 29, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041825
    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 (ID: 823832) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-3832 WITH LOT: 4610225, SHOWED 1 NR-REPORT: (B)(4) WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30 MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING AND FAILED THE TEST. THE VALVE WAS FLUSHED AND FAILED THE TEST AN OCCLUSION WAS NOTED. THE VALVE COULD NOT BE LEAK TESTED DUE TO THE OCCLUSION. THE VALVE COULD NOT BE REFLUX TESTED DUE TO THE OCCLUSION. THE CAM MECHANISM WAS GENTLY MOVED. THE VALVE WAS RETESTED FOR PROGRAMMING AND FAILED THE TEST. THE VALVE COULD NOT BE PRESSURE TESTED DUE TO THE OCCLUSION. THE VALVE WAS DISASSEMBLED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE WITH THE APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS NOTED ON THE RUBY BALL, ON THE CAM MECHANISM AND ON THE BASE PLATE. THE VALVE PASSED THE TEST FOR SIPHON GUARD. THE ROOT CAUSE FOR THE OCCLUSION PROBLEM REPORTED BY THE CUSTOMER WAS DUE TO BIOLOGICAL DEBRIS WAS STICKING THE RUBY BALL TO THE SEAT OF THE RUBY BALL. THE ROOT CAUSE FOR THE PROGRAMMING ISSUE NOTED DURING THE INVESTIGATION IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE CAM MECHANISM.

    Description of Event or Problem · 0

    A FACILITY REPORTED A PATIENT WAS SENT TO HOSPITAL ON (B)(6), 2021 AFTER A CAR ACCIDENT. ON (B)(6), 2021, A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE IMPLANTED DUE TO HYDROCEPHALUS. DURING A CT CHECK ON (B)(6) 2022, THE PHYSICIAN FOUND THAT THE HAKIM VALVE WAS OCCLUDED. THEN THEY CONDUCTED A REVISION PROCEDURE AND CHANGED WITH A NEW HAKIM VALVE (ID 823832). THE BACTISEAL CATHETER REMAINED IMPLANTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278999 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3832 4610225 10886704041825

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown