BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND SYSTEM ACCESS PORT I KIT

    MDR report key: 1963571 · Received December 20, 2010

    Report

    Report Number
    2024601-2010-01039
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    May 19, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. ANALYSIS NOTED A SMOOTH OPENING WITH LEAKAGE AT THE TAPER AND TUBING JUNCTION, CONSISTENT WITH WEAR AND TEAR. IN ADDITION, ANALYSIS NOTED PUNCTURES AND MISSING MATERIAL AT THE DAMAGED PORT SEPTUM AND EVIDENCE OF CORING LIKELY TO BE CAUSED BY THE USE OF A CORING NEEDLE. FURTHERMORE, ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. THE LAB NOTED A BLOCKAGE AND RESISTANCE TO FLOW ON THE ACCESS PORT. BIOLOGICAL TISSUE PARTICLES WERE FOUND ON AND IN BETWEEN THE PORT SEPTUM AND HOUSING. 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. CARE MUST BE TAKEN DURING AN ADJUSTMENT TO AVOID PUNCTURING THE TUBING WHICH CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION."

    Description of Event or Problem · 1

    ALLERGAN'S DEVICE ANALYSIS LAB RECEIVED A LAP-BAND ACCESS PORT. INITIALLY, IT WAS UNK WHY THE DEVICE WAS RETURNED. FOLLOW-UP FINDINGS: "OP [OPERATIVE] REPORT SHOWS THAT THE PT HAD A NEAR TRANSECTING OF HER LAP-BAND TUBING, RIGHT AT THE POINT WHERE THE THICKENING TUBING EXITING THE PORT NARROWED DOWN TO NORMAL SIZE TUBING, CAUSED A SEVERE LEAK WITH NO RESTRICTION." THE PORT WAS REMOVED AND REPLACED. THE PT HAD THE "LAP-BAND PLACED OVER A YEAR BEFORE" THE EXPLANT AND HAD "DIFFICULTY MAINTAINING RESTRICTION" SINCE THEN. DURING A FILL APPOINTMENT, A FLUOROSCOPY WAS PERFORMED AND IT SHOWED A LARGE LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND SYSTEM ACCESS PORT I KIT LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NONE REPORTED