BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM

    MDR report key: 3101810 · Received May 3, 2013

    Report

    Report Number
    2024601-2013-00315
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    January 28, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    UDI-DI
    10811955020145
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. 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."

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 06/11/2013. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. THE DEVICE ANALYSIS NOTED THAT THE BAND TUBING, AT VARIOUS SECTIONS, WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL CUTS TO REMOVE THE DEVICE, IN ADDITION TO A SHARP BREAKAGE THAT WAS ALSO NOTED ON ANOTHER SECTION OF THE BAND TUBING. THE ANALYSIS ALSO NOTED A SHARP (UNIDENTIFIED TEAR) OPENING IN THE BAND TUBING. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS, AND VISUAL EXAMINATION CONFIRMED THE CONNECTER TYPE AS TAPER II. VISUAL INSPECTION NOTED SCRATCHES ON THE RETURNED PORT, AND A PIECE OF BAND TUBING WAS RECEIVED SEPARATED FROM THE SS CONNECTOR. TWO SUPERFICIAL CUTS WERE OBSERVED ON THE TAPER NEAR THE PORT. LEAK TESTING WAS PERFORMED AND OBSERVED NO LEAKAGE OF THE ACCESS PORT. A FILL TEST WAS PERFORMED AND NO BLOCKAGE WAS OBSERVED OF THE ACCESS PORT. THE TUBING PIECE RETURNED WITH THE PORT WAS NOTED TO HAVE A HOLE THAT WAS APPROXIMATELY 1.0 X 1.5 MM. ONE OPEN END OF THE TUBING PIECE WAS FOUND TO HAVE STRIATIONS. THE OTHER OPEN END OF THE TUBING PIECE APPEARED ROUGH, AND APPEARED TO BE MISSING MATERIAL.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND "BROKEN TUBING" AND "LEAK/BREAK IN TUBING." THE EVENT WAS FIRST NOTED WHEN THE PATIENT REPORTED "SUDDEN LOSS OF SATIETY." THE "BROKEN TUBING PIECES" WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195260 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM LTI ALLERGAN NA 1274376 10811955020145

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR