BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I

    MDR report key: 1232690 · Received November 13, 2008

    Report

    Report Number
    2024601-2008-00882
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 17, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 11/13/2008. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS OF THE DEVICE NOTED DAMAGE FROM A SHARP INSTRUMENT TO THE BAND TUBING. PULLED MATERIAL FROM THE PORT SEPTUM WAS ALSO OBSERVED DURING THE ANALYSIS. THERE WAS NO INDICATION OF WEAR RELATED DAMAGE TO THE PORTION OF THE LAP-BAND SYSTEM RETURNED. PERFORMANCE TESTS INDICATE NO LEAKAGE AT THE ACCESS PORT OR ACCESS PORT TUBING. THE LAB WAS UNABLE TO DUPLICATE OR CONFIRM THE REPORTED EVENT. THERE IS NO OTHER INFORMATION AVAILABLE AT THIS TIME FROM THE SURGEON TO DETERMINE THE CAUSE OF THE ALLEGED EVENT. 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. IN ADDITION, THE LABELING ALSO ADDRESSES THE FOLLOWING POSSIBLE OUTCOME OF ACCESS PORT LEAKAGE: "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 BIOENTERICS LAP-BAND SYSTEM ACCESS PORT NEEDLES."

    Description of Event or Problem · 1

    REPORTED AS A PORT LEAK. ADDITIONAL FINDINGS PER THE DOCTOR AS, " WE COULDN'T IDENTIFY A LEAK IN SURGERY BUT THIS PORT WAS REPEATEDLY NOT HOLDING SALINE CLINICALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1288822

    Patients

    Seq Age Sex Outcome Treatment
    1 NI