BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ACCESS PORT KIT II (9.75, 10 CM)

    MDR report key: 1002578 · Received February 8, 2008

    Report

    Report Number
    2024601-2008-00049
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    December 20, 2007
    Report Date
    January 11, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER I: VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER I. ANALYSIS OF THE DEVICE NOTED BREAKAGE OF THE PORT TUBING LOCATED NEAR THE STAINLESS STEEL CONNECTOR (THIS IS THE PORTION OF TUBING LOCATED BETWEEN THE STAINLESS STEEL CONNECTOR AND THE PORT, NOT BETWEEN THE STAINLESS STEEL CONNECTOR AND THE BAND). THE BREAKAGE OF THE PORT TUBING MAY BE WEAR RELATED AS THERE IS NO CLEAR EVIDENCE OF SURGICAL DAMAGE. THIS BREAKAGE MAY HAVE BEEN THE CAUSE OF THE LEAKAGE. PERFORMANCE TESTS INDICATE LEAKAGE FROM THE ACCESS PORT BASE. THE LEAKAGE DOES NOT APPEAR TO BE RELATED TO THE REPORTED EVENT AND MAY HAVE OCCURRED DURING PORT REMOVAL AND REPLACEMENT OR MAY HAVE OCCURRED DURING ITS RETURN TO ALLERGAN. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." "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."

    Description of Event or Problem · 1

    REPORTED AS "RUPTURE CATHETER LINKING CHAMBER AND LAP BAND." (LEAK)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ACCESS PORT KIT II (9.75, 10 CM) DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1466863

    Patients

    Seq Age Sex Outcome Treatment
    1