BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 6110640 · Received November 17, 2016

    Report

    Report Number
    3006722112-2016-00353
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 8, 2016
    Report Date
    January 17, 2017
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. TO DATE, APOLLO HAS NOT RECEIVED THE DEVICE. DEVICE LABELING ADDRESSES THE EVENT OF DEFLATION AS FOLLOWS: WARNINGS AND PRECAUTIONS: THE RISK OF BALLOON DEFLATION AND INTESTINAL OBSTRUCTION (AND THEREFORE POSSIBLE DEATH RELATED TO INTESTINAL OBSTRUCTION) IS SIGNIFICANTLY HIGHER WHEN BALLOONS ARE LEFT IN PLACE LONGER THAN 6 MONTHS OR USED AT LARGER VOLUMES (GREATER THAN 700 CC). DEFLATED DEVICES SHOULD BE REMOVED PROMPTLY. 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. POSSIBLE COMPLICATIONS: POSSIBLE COMPLICATIONS OF THE USE OF ORBERA INCLUDE: BALLOON DEFLATION AND SUBSEQUENT REPLACEMENT.

    Additional Manufacturer Narrative · 1

    SUPPLEMENT #1 - MW SENT TO THE FDA ON 02/14/2017. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO APOLLO, AND A VISUAL INSPECTION WAS PERFORMED. THE DEVICE WAS NOTED TO HAVE BLUE DISCOLORATION ON THE SHELL OF THE BALLOON. WHITE, BROWN AND YELLOW PARTICLES WERE OBSERVED ON THE OUTER SURFACE OF THE BALLOON SHELL AND VALVE. A VALVE TEST WAS PERFORMED AND FLOW WAS CONTINUOUS AND UNOBSTRUCTED. AN AIR LEAK TEST WAS PERFORMED AND LEAKAGE WAS OBSERVED IN TWO LOCATIONS. MICROSCOPIC ANALYSIS NOTED TWO STRIATED OPENINGS ON THE SHELL OF THE DEVICE, CONSISTENT WITH DEVICE REMOVAL. BROWN AND BLACK PARTICLES WERE OBSERVED IN THE VALVE CHANNEL.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA INTRAGASTRIC BALLOON HAD "REPORTED BLUE URINE. PERFORMED EDA (ENDOSCOPY) IT WAS NOTICED BLUE IN THE HIGH BODY OF THE STOMACH. PROBABLY BALLOON LEAKED THROUGH THE VALVE." DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761010 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50000 2742178

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR