BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 3893810 · Received June 25, 2014

    Report

    Report Number
    1226348-2014-11749
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    March 20, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER WAS CPFBWH, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3834. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS VISUALLY INSPECTED, IT WAS NOTED THAT THE PROXIMAL CONNECTOR WAS DISCONNECTED, THIS COULD BE DUE TO WRONG HANDLING WHEN EXPLANTING THE VALVE. THE VALVE WAS IRRIGATED WITH PURIFIED WATER; AN OCCLUSION WAS NOTED AT THE INLET OF THE RUBY BALL. THEREFORE A FINE NEEDLE WAS INSERTED INTO THE FLOW OPENING OF THE VALVE INLET UNDER THE RUBY BALL AND ITS SEAT, THE RUBY BALL WAS MANUALLY POPPED FREE FROM ITS STUCK POSITION USING LIGHT FORCE. THE VALVE WAS IRRIGATED AGAIN, NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSIONS WERE NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED; NO LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE FAILED THE TEST, DURING THE PROGRAMMING PROCESS THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS THEN PRESSURE TESTED AT 70MMH2O, THE VALVE FAILED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND COVERING THE VALVE MECHANISM. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3834 WITH LOT NUMBER CPFBWH, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 14TH MAY 2013. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS DUE TO BIOLOGICAL DEBRIS FOUND COVERING THE VALVE MECHANISM. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED VIA V-P SHUNT TO THE PATIENT WITH INPH IN 2012. DOI AND THE INITIAL SETTING PRESSURE WERE UNKNOWN. THE SURGEON LOWERED THE SETTING PRESSURE SINCE THE PATIENT COMPLAINED HER HEADACHE AND VOMITING. HOWEVER, THE PATIENT'S CONDITION WAS NOT IMPROVED EVEN AFTER FLASHING. THE CONTRAST RADIOGRAPHY WAS CONDUCTED AND IT WAS FOUND THE OCCLUSION OF THE DEVICE. THE SURGEON SUSPECTED THE ABDOMINAL CATHETER COULD BE OCCLUDED. THEREFORE, THE REVISION WAS CONDUCTED ON (B)(4) 2014 AND THE DEVICE WAS REPLACED WITH ANOTHER DEVICE ((B)(4)). THE SETTING PRESSURE OF BOTH REMOVED VALVE AND REPLACED VALVE WAS UNKNOWN. THE INCIDENT WAS REPORTED TO JJKK ON (B)(4) 2014. THE CUSTOMER REQUESTS TO OBTAIN INFORMATION FOR THE RESULT OF PRESSURE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371351 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPFBWH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention