BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1883212 · Received October 20, 2010

    Report

    Report Number
    2024601-2010-00837
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    May 24, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH TO FDA ON: (B)(4) 2010. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED A THINNER SURFACE AND SMOOTH OPENING AT THE TAPER TUBING JUNCTION CONSISTENT WITH WEAR AND TEAR. ANALYSIS NOTED PULLED MATERIAL AT THE DAMAGED PORT SEPTUM AND EVIDENCE OF CORING LIKELY TO BE CAUSED BY THE USE OF A CORING NEEDLE. THE LAB NOTED THAT AFTER FLUSHING, THE PORT HOUSING PARTICLES WERE OBSERVED COMING OUT. THE PORT HOUSING APPEARED TO BE COATED WITH A WHITE OPAQUE COLOR OF AN UNK SUBSTANCE, AND THE LAB NOTED THAT THE PORT APPEARS "DETERIORATE." ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. FURTHER INFO FROM THE REPORTER REGARDING THE MODEL, SERIAL NUMBER, PT DATA, EVENT AND THE IMPLANT DATE HAS BEEN REQUESTED. 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." IN ADDITION, THE LABELING ALSO ADDRESSES THE FOLLOWING POSSIBLE OUTCOME OF ACCESS PORT LEAKAGE: "CAUTION: WHEN ADJUSTING BAND VOLUME, USE OF AN INAPPROPRIATE NEEDLE MAY CAUSE ACCESS PORT LEAKAGE AND REQUIRE RE-OPERATION TO REPLACE THE PORT. USE ONLY LAP-BAND SYSTEM ACCESS PORT NEEDLES. DO NOT USE STANDARD HYPODERMIC NEEDLES, AS THESE MAY CAUSE LEAKS." "CAUTION: USE OF AN INAPPROPRIATE NEEDLE MAY CAUSE ACCESS PORT LEAKAGE AND REQUIRE REOPERATION TO REPLACE THE PORT. DO NOT USE STANDARD HYPODERMIC NEEDLES AS THESE MAY CAUSE LEAKS. USE ONLY LAP-BAND SYSTEM ACCESS PORT NEEDLES."

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS "THERE WAS A LEAK IN PORT TUBING AND THE SURGEON SUBSTITUTES THE PORT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI