BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBALON BALLOON SYSTEM

    MDR report key: 8000903 · Received October 24, 2018

    Report

    Report Number
    3009256831-2018-00650
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    PMA / PMN Number
    P160001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON INFLATION PRESSURES WERE RECORDED AS WITHIN THE PRESSURE RANGE AT IMPLANTATION. BASED ON THE IMPLANTATION DATES, ALL BALLOONS HAD BEEN IMPLANTED OVER 6 MONTHS. THE FIRST, SECOND, AND THIRD BALLOONS WERE IMPLANTED FOR 229 DAYS, 207 DAYS, AND 186 DAYS, RESPECTIVELY. A POTENTIAL ROOT CAUSE OF THE DEFLATION COULD BE MATERIAL FATIGUE RESULTING FROM LOW BALLOON PRESSURE, HOWEVER THE ACTUAL ROOT CAUSE REMAINS UNKNOWN. 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." DEFLATION IS A KNOWN RISK; THE FREQUENCY OF BALLOON DEFLATIONS TO DATE HAS NOT EXCEEDED THE FREQUENCY IDENTIFIED IN THE LABELING. OBALON'S LABELING ADDRESSES THIS TYPE OF REPORTED EVENT WITH WARNINGS FOR MONITORING PATIENTS FOR DEFLATION SYMPTOMS AND THE INCREASED RISK OF NOT REMOVING BALLOONS AFTER 6 MONTHS FROM THE FIRST IMPLANTATION DATE.

    Description of Event or Problem · 1

    A FEMALE PATIENT HAD A FIRST BALLOON IMPLANTATION DATE OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018. REFLUX ESOPHAGITIS WAS FOUND DURING THE PATIENT'S UPPER GI CONDUCTED PRIOR TO THE FIRST BALLOON PLACEMENT. PATIENT PRESENTED TO THE PRESCRIBING PHYSICIAN'S CLINIC WITH NEW ONSET OF SYMPTOMS OF NAUSEA, REPORTED BLOOD IN EMESIS, ABDOMINAL PAIN, AND DIARRHEA ON (B)(6) 2018. DUE TO PERSISTENT EMESIS, THE PRESCRIBING PHYSICIAN DETERMINED REMOVAL USING PRECAUTIONARY INTUBATION WAS WARRANTED AND SENT THE PATIENT TO A HOSPITAL FACILITY WITH PROPER EQUIPMENT. BALLOON REMOVAL OCCURRED SAME DAY. AT ENDOSCOPY ONE BALLOON WAS IDENTIFIED AT THE PYLORIC CHANNEL AND CAUSING INTERMITTENT OBSTRUCTION. NO TEARS IN THE STOMACH MUCOSA OR ESOPHAGUS WERE IDENTIFIED AT REMOVAL. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND WERE DISCARDED, THEREFORE THE BALLOONS WERE NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839383 OBALON BALLOON SYSTEM INTRAGASTIC BALLOON LTI OBALON THERAPEUTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other