BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ACCESS PORT KIT II (9.75, 10.0 CM)

    MDR report key: 1041317 · Received May 9, 2008

    Report

    Report Number
    2024601-2008-00243
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 10, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 05/09/2008. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS OF THE DEVICE NOTED AN OPENING ON THE PROT TUBING LOCATED IN BETWEEN THE PORT/INJECTION SITE AND THE STAINLESS STEEL CONNECTOR. THE OPENING ON THE PORT TUBING MAY BE WEAR RELATED AS THERE'S NO CLEAR EVIDENCE OF SURGICAL DAMAGE. THIS OPENING MAY HAVE BEEN THE CAUSE OF THE LEAKAGE. ANOTHER BREAKAGE WAS NOTED IN THE BAND TUBING WHICH APPEARS TO HAVE BEEN CAUSED BY A SHARP INSTRUMENT. THIS BREAKAGE MAY HAVE BEEN MADE TO FACILITATE REMOVAL OF THE DEVICE, AND MAY NOT BE THE CAUSE OF THE LEAKAGE. 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 BY THE PT AS A PORT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ACCESS PORT KIT II (9.75, 10.0 CM) DEVICE FOR TREATMENT OF MOBID OBESITY LTI COSTA RICA NA 1025700

    Patients

    Seq Age Sex Outcome Treatment
    1