BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 17650869 · Received August 30, 2023

    Report

    Report Number
    3013886523-2023-00291
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 10, 2023
    Report Date
    November 3, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041481
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 823113) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR)- PRODUCT CODE 82-3113 WITH LOT CJDC56, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 7. THE VALVE WAS VISUALLY INSPECTED; THE DISTAL CONNECTOR WAS DISLODGED. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING AND FAILED. THE TESTS FOR FLUSH, LEAK AND PRESSURE COULD NOT BE PERFORMED AS THE DISTAL CONNECTOR WAS DISLODGED. THE VALVE PASSED THE TEST FOR REFLUX. THE VALVE WAS DISASSEMBLED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE RUBY BALL, MOTOR AND ON THE SEAT OF THE RUBY BALL. THE VALVE WAS VISUALLY INSPECTED MAGNETIZING ENGINES TESTED, PASSED. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE ANALYSIS- THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE, AT THE TIME OF INVESTIGATION BIOLOGICAL DEBRIS WERE NOTED. THE ROOT CAUSE FOR THE PRESSURE ISSUE NOTED DURING THE INVESTIGATION IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE RUBY BALL AND ON THE CAM / BALL ARM ASSEMBLY AS WELL AS THE RC, THE DEBRIS WAS STOPPING THE RUBY BALL FROM BEING SEATED CORRECTLY.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823113) WAS IMPLANTED VIA VENTRICULOPERITONEAL SHUNT IN (B)(6) 2008 WITH UNKNOWN SETTING. ON UNKNOWN DATE, THE PATIENT CAME TO THE HOSPITAL FOR A ROUTINE CHECK-UP. X-RAYS WERE PERFORMED AND VENTRICULAR ENLARGEMENT WAS OBSERVED. AN ATTEMPT WAS MADE TO CHANGE THE SET PRESSURE WITH A POWERFUL MAGNET, BUT THE CHANGE WAS UNSUCCESSFUL. THE PATIENT HAD NO CLINICAL SYMPTOMS, BUT AS A PRECAUTION, A REVISION SURGERY WAS PERFORMED FOR FUTURE MANAGEMENT. THE VALVE WAS REMOVED AND REPLACED ON (B)(6), 2023. THE PATIENT RECOVERED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302584 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 10886704041481

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male