BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAVITY COMPESATING ACCESSORY, IOW

    MDR report key: 2997150 · Received March 5, 2013

    Report

    Report Number
    9612007-2013-00008
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K932429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A REPORT WAS REC'D INVOLVING A GRAVITY COMPENSATING ACCESSORY DEVICE WHICH WAS DESCRIBED AS FOLLOWS; "THE CUSTOMER NOTICED A LIQUID LEAKAGE FROM THE (GCA) GRAVITY COMPENSATING ACCESSORY DEVICE WHEN THE PERITONEAL CATHETER WAS CONNECTED TO THE PROXIMAL AND DISTAL CONNECTORS. APPARENTLY, THE LIQUID LEAKAGE OCCURRED THROUGH THE GCA OUTER CASING. THE SURGEON INFORMED US THAT IT DIDN'T SEEM THAT THE LIQUID ESCAPED THROUGH THE "SEALING LINE" OF THE TWO PARTS OF THE OUTER CASING. THE INCIDENT OCCURRED WHEN THE GCA WAS CONNECTED TO THE PERITONEAL CATHETER IN A PT WITH AN ALREADY IMPLANTED VALVE SYSTEM. THE GCA WAS CONNECTED TO THE PERITONEAL CATHETER MAKING AN INCISION UNDER THE PECTORAL TO SHOW THE CATHETER, CUT IT AND CONNECT THE GCA OPPOSITE ENDS TO THE CATHETER OPPOSITE ENDS. WHEN THE CONNECTION WAS DONE THE GCA WAS INTRODUCED IN THE SUBDERMAL BUTTONHOLE IN SUCH A WAY THAT IT IS IN VERTICAL POSITION WHEN THE PT IS STANDING UP. THE SURGEON INFORMED US ABOUT A RELEVANT DETAIL WHICH COULD BE VERY IMPORTANT. BEFORE CLOSING THE INCISION THE SURGEONS CARRIED OUT A "FLUSH" FROM THE RESERVOIR TO THE VALVE (THEY PUSHED THE VALVE WITH A FINGER THROUGH THE SKIN, THE VENTRICULAR CATHETER HAD BEEN BLOCKED PREVIOUSLY WITH OTHER FINGER, SO THE LIQUID INSIDE THE VALVE IS DRAINED TOWARDS TO THE PERITONEAL CATHETER AND IN THIS CASE TO THE GCA) WHEN THE "FLUSH" WAS DONE THE SURGEON NOTICED THE LIQUID LEAKAGE THROUGH THE GCA OUTER CASING. THEN THEY CHANGED THE GCA DEVICE, BUT THEY NOTICED THAT SECOND ONE HAD THE SAME PROBLEM. THE EVENT LED TO INCREASED SURGERY TIME BUT IS UNK FOR HOW LONG." THE "FLUSH MANEUVER IS NOT USUALLY PERFORMED BY THESE SURGEONS, SO THEY ARE VERY WORRIED BECAUSE THEY AREN'T SURE WHETHER OTHER IMPLANTED GCA MAY HAVE EXPERIENCED THIS PROBLEM WITHOUT THEIR KNOWLEDGE. WE DON'T KNOW IF THE "FLUSH" MANEUVER PRODUCES SUCH HIGH PRESSURE INSIDE THE GCA THAT IT COULD CAUSE THIS PROBLEM. WE HAVE TO TAKE INTO ACCOUNT THAT WHEN THE RESERVOIR IS PUSHED ALL THE LIQUID INSIDE THE RESERVOIR + VALVE + PERITONEAL CATHETER GOES VERY FAST TO THE GCA AND THE PRESSURE IS PROPORTIONAL TO THE FINGER PUSHING FORCE AND IT'S AFFECTED BY THE INNER CATHETER DIAMETER (LESS DIAMETER/HIGH PRESSURE). THE SURGEON REPORTED THAT THE TWO DEFECTIVE GCA'S WERE USED FOR THE SAME PT AND THEN THEY OPENED A THIRD GCA WHICH WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94359 GRAVITY COMPESATING ACCESSORY, IOW ANTI-SIPHON DEVICE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 0173397

    Patients

    Seq Age Sex Outcome Treatment
    1