BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 3871556 · Received June 13, 2014

    Report

    Report Number
    1226348-2014-11704
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 16, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3MM OF CATHETER WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED 3MM OF CATHETER DID NOT CONFIRM A PROBLEM. THE LOT NUMBER WAS UNKNOWN, PRODUCT CODE (B)(4). 3MM OF CATHETER WERE VISUALLY INSPECTED, NO DEFECTS WERE NOTED. ONE END SEEMS TO BE CLEAN CUT, AND THE OTHER NOT SO CLEAN CUT. REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. NO ROOT CAUSE COULD BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. DEVICE IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED VIA V-P SHUNT TO THE PATIENT AT 120 MMH2O ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT HAD SUBARACHNOID HEMORRHAGE. AFTER IMPLANTATION, OVER DRAINAGE WAS NOTED WITH THE PATIENT. THE PATIENT¿S CONDITION HAD NOT BEEN IMPROVED EVEN AFTER THE SETTING PRESSURE CHANGED TO 140MMH2O. SINCE IT WAS FOUND THE VENTRICULAR CATHETER HAD BEEN DISLODGED, THE RECONNECTION SURGERY WAS CONDUCTED ON (B)(6) 2014. THE CATHETER IN QUESTION WAS CUT ABOUT 3MM FROM THE END SIDE THAT IS CONNECTED THE VALVE AND RECONNECTED TO THE VALVE AT THIS SURGERY. ACCORDING TO THE SURGEON, THE CATHETER IN QUESTION COULD BE BROKEN WHEN THE PATIENT FELL DOWN, WHICH PROBABLY CAUSED THE CATHETER LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349789 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention