BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLIN VLV ONLY W/ SPHNGD

    MDR report key: 3790038 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11524
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED TO SUBMIT AN MDR RECLASSIFYING THE INCIDENT AS A MALFUNCTION. UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 4. 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 AND THE FLOW WAS NORMAL. THE SIPHON GUARD WAS IRRIGATED AND THE FLOW WAS NORMAL. THE VALVE WAS DRIED. THE VALVE WAS TESTED FOR PROGRAMMING AND FAILED THE TEST; DURING THE PROGRAMMING PROCESS THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS THEN PRESSURE TESTED AT SETTING 4, AND PASSED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM PILLAR, AND ON THE SPRING. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEW AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INVESTIGATION, THIS COMPLAINT IS CONSIDERED CLOSED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, A FLOW IMPEDIMENT OF THE VALVE HAS BEEN OBSERVED. THE VALVE HAS BEEN IMPLANTED ON (B)(6) 2012 AND EXPLANTED DURING THE SAME PROCEDURE. REPLACEMENT OF VALVE UNKNOWN. NO PATIENT OUTCOME REPORTED. (B)(4) AFFILIATE CONFIRMED THAT THE EVENT WAS INTRA-OPERATIVE. THE PATIENT GOT ANOTHER VALVE. NO HARM FOR THE PATIENT AND NO DELAY GREATER THAN 30 MINUTES REPORTED. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED TO SUBMIT AN MDR RECLASSIFYING THE INCIDENT AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269367 CERTAS INLIN VLV ONLY W/ SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1