BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND SYSTEM ACCESS PORT

    MDR report key: 6194656 · Received December 21, 2016

    Report

    Report Number
    3006722112-2016-00397
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    September 13, 2016
    Report Date
    November 24, 2016
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER: THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED BY APOLLO. IF RETURNED, VISUAL EXAMINATION MAY DETERMINE THE CONNECTER TYPE ASSOCIATED WITH THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF "LEAK(S)" AS FOLLOWS: PRECAUTIONS: CARE MUST BE TAKEN DURING BAND ADJUSTMENT TO AVOID PUNCTURING THE TUBING WHICH CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION. FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE. IN ORDER TO AVOID INCORRECT PLACEMENT, THE PORT SHOULD BE PLACED LATERAL TO THE TROCAR OPENING AND A POCKET MUST BE CREATED FOR THE PORT, SO THAT IT IS PLACED FAR ENOUGH FROM THE TROCAR PATH TO AVOID ABRUPT KINKING OF THE TUBING. ADVERSE EVENTS: DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTING TUBING. WARNINGS: PATIENTS SHOULD BE ADVISED THAT THE LAP-BAND AP® SYSTEM IS A LONG-TERM IMPLANT. EXPLANT AND REPLACEMENT SURGERY MAY BE INDICATED AT ANY TIME. MEDICAL MANAGEMENT OF ADVERSE REACTIONS MAY INCLUDE EXPLANTATION. REVISION SURGERY FOR EXPLANTATION AND REPLACEMENT MAY ALSO BE INDICATED TO ACHIEVE PATIENT SATISFACTION.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH LAP-BAND SYSTEM WAS REPORTED TO HAVE "PROBLEM WITH THE PORT ACCESS. POSSIBLE LEAK NEEDED TO TEST THE PORT WITH THE NEEDLE KIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845688 LAP-BAND SYSTEM ACCESS PORT ADJUSTABLE GASTRIC BAND ACCESS PORT LTI APOLLO ENDOSURGERY, INC. B-2265 2703025

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR