BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID PORT EZ

    MDR report key: 2032733 · Received February 14, 2011

    Report

    Report Number
    2032733
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING PLACEMENT OF AN ALLERGAN LAP BAND. THE BAND WAS PLACED SUCCESSFULLY AND THE SURGEON PROCEEDED TO PLACING THE IMPLANTABLE PORT (USED TO ADJUST FLUID LEVEL IN BAND). THE SURGEON WAS PLACING ONE OF THE NEW RAPIDPORT EZ PORTS USING THE PORT APPLIER. THIS PORT APPLIER "FIRES" 4 STAINLESS STEEL FASTENERS (ON THE BOTTOM OF THE PORT) WHICH ADHERE TO THE RECTUS MUSCLE FASCIA. IMMEDIATELY UPON "FIRING" THE APPLIER, THE SURGEON NOTED A SMALL AMOUNT OF BLEEDING AND FELT HE MAY HAVE STRUCK A VESSEL. THE SURGEON RE-ENGAGED THE ACCESS PORT WITH THE PORT APPLIER AND ONCE ENGAGED PRESSED THE UNLOCK BUTTON TO RETRACT THE STAINLESS STEEL FASTENERS. UPON RETRACTING ONE OF THE FASTENERS, TWISTED TOWARDS THE INSIDE OF THE PORT AND WOULD NOT ALIGN AGAIN WITH THE HOLE THE FASTENER LOCKS INTO. THE OTHER 3 FASTENERS ALSO WOULD NOT OPEN PROPERLY AT THIS POINT. THE SURGEON HAD TO MANIPULATE THE PORT TO EVENTUALLY GET IT REMOVED AND OPTED TO REPLACE IT WITH AN OLD SUTURE TYPE PORT (FROM ALLERGAN). HEMOSTATIS WAS ACHIEVED AND THE PROCEDURE PROCEEDED WITH NO FURTHER ISSUES. THE PT WAS SENT TO PACU FOR RECOVERY. THE PORT HAS BEEN RETAINED IN OUR OFFICE (RISK MGMT) AND WILL ONLY BE RETURNED TO MFG FOR EVALUATION WITH A SIGNED RELEASE FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID PORT EZ ALLERGAN RAPIDPORT EZ PORT APPLIER LTI ALLERGAN B-2360 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR