BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 3181993 · Received June 17, 2013

    Report

    Report Number
    2024601-2013-00562
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    September 24, 2012
    Report Date
    February 18, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. LAB ANALYSIS NOTED OBSERVATION OF NEEDLE INDUCED SEAL DAMAGE TO ACCESS PORT. ANALYSIS OF THE DEVICE ALSO FOUND AN OPENING IN THE PORT TUBING BETWEEN THE STAINLESS STEEL CONNECTOR AND THE INJECTION SITE. ANALYSIS OF THE DEVICE NOTED AN ADHESIVE FAILURE, BETWEEN THE ACCESS PORT HOUSING AND THE TAPER CONNECTOR. ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. 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: CARE MUST BE TAKEN DURING BAND ADJUSTMENT TO AVOID PUNCTURING THE TUBING WHICH CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION." DEVICE LABELING ADDRESSES THE FOLLOWING PRECAUTION TO PREVENT DAMAGE TO THE PORT: "WHEN ADJUSTING BAND VOLUME, ONCE THE SEPTUM IS PUNCTURED, DO NOT TILT OR ROCK THE NEEDLE, AS THIS MAY CAUSE FLUID LEAKAGE OR DAMAGE TO THE SEPTUM." "CAUTION: ONCE THE SEPTUM IS PUNCTURED, DO NOT TILT OR ROCK THE NEEDLE, AS THIS MAY CAUSE FLUID LEAKAGE OR DAMAGE TO THE SEPTUM."

    Description of Event or Problem · 1

    NO INFORMATION REGARDING EVENT. EXPLANTED DEVICE TO BE RETURNED. FOLLOW-UP FINDINGS: "PORT REPLACEMENT." REASON NOT PROVIDED. FOLLOW-UP FINDINGS: "PATIENT WAS HAVING FLUID CHECKS BECAUSE SMALL LEAKS NEVER SHOW UP ON X-RAY, CONFIRMED LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273624 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 2097424

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR