BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 6070609 · Received November 1, 2016

    Report

    Report Number
    3006722112-2016-00315
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 3, 2016
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020619
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON 11/01/2016. FURTHER INFORMATION HAS BEEN REQUESTED OF THE INITIAL REPORTER REGARDING: DEVICE SERIAL NUMBER, FILL VOLUME AND FILL SOLUTION. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY APOLLO. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO APOLLO, AND A VISUAL INSPECTION WAS PERFORMED. BLUE AND BROWN DISCOLORATION WAS OBSERVED ON THE SHELL. BROWN DISCOLORATION WAS OBSERVED IN THE VALVE HOLE. BROWN PARTICLES WERE OBSERVED ON THE OUTER SURFACE OF THE DEVICE. A VALVE TEST WAS PERFORMED AND FLOW WAS CONTINUOUS AND UNOBSTRUCTED. AN AIR LEAK TEST WAS PERFORMED AND LEAKAGE WAS OBSERVED. UNDER MICROSCOPIC ANALYSIS TWO NEEDLE PUNCTURES AND TWO STRIATED OPENINGS WERE OBSERVED ON THE SHELL, CONSISTENT WITH DEVICE REMOVAL ACTIVITIES. TWO NON-PENETRATING NICKS WERE OBSERVED ON THE SHELL OF THE DEVICE. DEVICE LABELING ADDRESSES THE EVENT AS FOLLOWS: PRECAUTIONS: THE PHYSIOLOGICAL RESPONSE OF THE PATIENT TO THE PRESENCE OF ORBERA MAY VARY DEPENDING UPON THE PATIENT'S GENERAL CONDITION AND THE LEVEL AND TYPE OF ACTIVITY. THE TYPES AND FREQUENCY OF ADMINISTRATION OF DRUGS OR DIET SUPPLEMENTS AND THE OVERALL DIET OF THE PATIENT MAY ALSO AFFECT THE RESPONSE. EACH PATIENT MUST BE MONITORED CLOSELY DURING THE ENTIRE TERM OF TREATMENT IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE COMPLICATIONS. EACH PATIENT SHOULD BE INSTRUCTED REGARDING SYMPTOMS OF DEFLATION, GASTROINTESTINAL OBSTRUCTION, ULCERATION AND OTHER COMPLICATIONS WHICH MIGHT OCCUR, AND SHOULD BE ADVISED TO CONTACT HIS/HER PHYSICIAN IMMEDIATELY UPON THE ONSET OF SUCH SYMPTOMS. ADVERSE EVENTS: IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. COMPLICATIONS THAT MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE ENDOSCOPIC PROCEDURE, THE RISKS ASSOCIATED WITH ANY ENDOSCOPIC PROCEDURE, THE RISKS ASSOCIATED WITH THE ORBERA INTRAGASTRIC BALLOON SPECIFICALLY, AND THE RISKS ASSOCIATED WITH THE PATIENT'S DEGREE OF INTOLERANCE TO A FOREIGN OBJECT PLACED IN THE STOMACH.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA INTRAGASTRIC BALLOON HAD "HYPERINFLATION, EARLY REMOVAL." THE INFLATION WAS OBSERVED DURING A UGI (UPPER GASTROINTESTINAL) SERIES. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720773 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-4800 NI 10811955020619

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR NEXIUM