BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBALON BALLOON SYSTEM

    MDR report key: 8591342 · Received May 8, 2019

    Report

    Report Number
    3009256831-2019-00172
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 8, 2019
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    UDI-DI
    00859810006067
    PMA / PMN Number
    P160001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON INFLATION PRESSURES WERE RECORDED AS WITHIN THE ACCEPTABLE PRESSURE RANGE AT IMPLANTATION. THE ROOT CAUSE IS UNKNOWN IN PARTICULAR SINCE THE DEFLATED BALLOON WAS NOT RETURNED FOR INVESTIGATION. DEFLATION IS A KNOWN RISK AND THE FREQUENCY OF BALLOON DEFLATIONS TO DATE HAS NOT EXCEEDED THE FREQUENCY INCLUDED IN THE LABELING. PER THE LABELING "PATIENTS REPORTING A LOSS OF FULLNESS, INCREASED HUNGER, AND/OR WEIGHT GAIN SHOULD BE EXAMINED BY RADIOGRAPH, AS THIS MAY BE A SIGN OF BALLOON DEFLATION. ADDITIONALLY, ANY INCREASE IN NAUSEA, VOMITING AND/OR CRAMPING AFTER INITIAL SYMPTOMS HAVE SUBSIDED MAY INDICATE A DEFLATED BALLOON. PATIENTS SHOULD BE EVALUATED BY RADIOGRAPH AND ENDOSCOPIC VISUALIZATION MIGHT BE REQUIRED IF THE STATE OF INFLATION CANNOT BE DETERMINED RADIOGRAPHICALLY. IN THE EVENT OF BALLOON DEFLATION, THE BALLOON SHOULD BE REMOVED AS SOON AS POSSIBLE." THE INSTRUCTION FOR USE CONTAINS THE FOLLOWING WARNING: "THE RISK OF BALLOON DEFLATION IS SIGNIFICANTLY HIGHER WITH BALLOONS THAT ARE LEFT LONGER THAN 6 MONTHS".

    Description of Event or Problem · 1

    A SINGLE BALLOON WAS FOUND TO BE NO LONGER LOCATED IN THE STOMACH DURING A SCHEDULED ENDOSCOPIC REMOVAL ON (B)(6) 2019 IN A PATIENT WITH THREE BALLOONS, FIRST BALLOON PLACEMENT ON (B)(6) 2018, SECOND BALLOON PLACEMENT ON (B)(6) 2018, AND THIRD BALLOON PLACEMENT ON (B)(6) 2018. THE REMAINING BALLOONS LOCATED IN THE STOMACH WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION BUT WERE NOT RETURNED FOR INVESTIGATION. THE PATIENT RECEIVED AN ABDOMINAL X-RAY ON (B)(6) 2019 THAT SHOWED NO SIGNS OF A DEFLATED BALLOON LOCATED IN THE INTESTINAL TRACT. THE PATIENT DID NOT EXPERIENCE SYMPTOMS CONSISTENT WITH BOWEL OBSTRUCTION OR REPORT A NEW ONSET OF SYMPTOMS TO THEIR PRESCRIBING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385798 OBALON BALLOON SYSTEM INTRAGASTIC BALLOON LTI OBALON THERAPEUTICS, INC. 7600-0001 00859810006067

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR