BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2121852 · Received May 20, 2011

    Report

    Report Number
    2024601-2011-00420
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE REPORTER REGARDING ADD'L DETAILS ON THE EVENT, THE SERIAL NUMBER, PT DATA AND THE EVENT, IMPLANT AND EXPLANT DATES HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DIFFICULTY ADDING/REMOVING SALINE AS FOLLOWS: "IT IS IMPORTANT TO REMOVE ANY ADD'L SALINE VIA THE ACCESS PORT SO NO AIR WILL ENTER THE LAP-BAND SYSTEM, COMPROMISING LATER ADJUSTMENTS. IF YOUR PT'S ANATOMY REQUIRES A LARGER INITIAL CIRCUMFERENCE, THE PERIMETER OF THE LAP-BAND AP SYSTEM CAN BE MADE LARGER BY REMOVING SALINE FROM THE BAND VIA THE ACCESS PORT. IT IS IMPORTANT TO REMOVE ANY ADD'L SALINE VIA THE ACCESS PORT SO NO AIR WILL ENTER THE LAP-BAND SYSTEM, COMPROMISING LATER ADJUSTMENTS." "CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE." "PENETRATE THE ACCESS PORT. THE PORT MUST BE PENETRATED UNTIL THE NEEDLE IS STOPPED BY THE BOTTOM OF THE PORTAL CHAMBER. WITHDRAW SOME SALINE TO CONFIRM THAT THE BEVEL OF THE NEEDLE IS WITHIN THE PORT. IF, AFTER PENETRATION, THE SALINE SOLUTION CANNOT BE WITHDRAWN OR INJECTED, THE BEVEL OF THE NEEDLE MAY BE OCCLUDED BY THE PORT SEPTUM. TRY TO ADVANCE THE NEEDLE FURTHER INTO THE PORT TO THE BOTTOM OF THE PORTAL CHAMBER. IF YOU CANNOT ADVANCE, THEN RE-ENTER THE PORT WITH ANOTHER STERILE NEEDLE." "FAILURE TO USE THE TUBING END PLUG DURING PLACEMENT OF THE BAND MAY RESULT IN DAMAGE TO THE BAND TUBING DURING BAND PLACEMENT." "AN END PLUG IS PROVIDED TO SEAL THE SYSTEM WHILE THE BAND IS BEING PASSED AROUND THE STOMACH."

    Description of Event or Problem · 1

    THE SURGEON REPORTED A BLOCKAGE IN THE LAPBAND DUE TO COAGULATED BLOOD - BLOCKAGE IDENTIFIED BY X-RAY. SURGEON COULD NOT GET FLUID IN OR OUT. DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI