BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 6122092 · Received November 22, 2016

    Report

    Report Number
    3006722112-2016-00355
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 16, 2016
    Report Date
    February 16, 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

    SUPPLEMENT #1 - MEDWATCH SENT TO FDA ON 02/27/2017. ADDITIONAL INFORMATION: REPORT DATE, DEVICE AVAILABLE FOR EVALUATION?, DATE RECEIVED BY MFR?, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, EVALUATION CODES. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO APOLLO, AND A VISUAL INSPECTION WAS PERFORMED. WHITE FLUID WAS NOTED ON THE OUTER SURFACE OF THE SHELL AND VALVE PATCH. THE VALVE CHANNEL/HOLE WAS NOTED TO BE DISCOLORED, BLUE IN COLOR. WHITE PARTICLES WERE NOTED ON THE OUTER SURFACE OF THE SHELL. A VALVE TEST WAS PERFORMED, AND NO BLOCKAGE WAS NOTED. AN AIR LEAK TEST WAS PERFORMED AND THE BALLOON WAS LEAKING FROM TWO SEPARATE OPENINGS ON THE SHELL. UNDER MICROSCOPIC ANALYSIS, THE THREE OPENINGS ON THE SHELL NOTED AND APPEARED TO BE STRIATED, CONSISTENT WITH DAMAGE FROM A REMOVAL TOOL. BROWN PARTICLES WERE NOTED IN THE VALVE CHANNEL/HOLE.

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON 11/22/2016. 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 REPORTED ADVERSE 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 OF THE USE OF THE ORBERA SYSTEM INCLUDE: BALLOON DEFLATION AND SUBSEQUENT REPLACEMENT.

    Description of Event or Problem · 1

    A PATIENT WITH THE ORBERA INTRAGASTRIC BALLOON HAD COMPLAINED OF BLUE URINE THREE DAYS AFTER PLACEMENT. AN ENDOSCOPY WAS PERFORMED AND CONFIRMED THE "EMPTY BALLOON." DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773291 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50000 2744851

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR