BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBALON BALLOON SYSTEM

    MDR report key: 8180522 · Received December 19, 2018

    Report

    Report Number
    3009256831-2018-00777
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 19, 2018
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    PMA / PMN Number
    P160001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFLATED BALLOON WAS THE SECOND BALLOON IMPLANTED OF THE THREE-BALLOON SYSTEM AND WAS IMPLANTED FOR A DURATION OF 183 DAYS. THE BALLOON INFLATION PRESSURE WAS RECORDED AS WITHIN THE LABELED PRESSURE RANGE AT IMPLANTATION. OBALON INITIATED A TECHNICAL INVESTIGATION OF THE PRODUCT FAILURE INCLUDING ENGINEERING ANALYSIS AND A THIRD-PARTY LABORATORY FOR CULTURE ANALYSIS ON THE RETURNED DEFLATED BALLOON. THE BALLOON VOLUME WAS WITHIN THE EXPECTED VOLUME SPECIFICATION. THE CULTURE ANALYSIS RESULTS FROM SAMPLE SWABS FROM THE BALLOONS SHOWED DETECTION OF FUNGI COMMONLY IDENTIFIED IN THE GUT FLORA AND NO DETECTION OF BACTERIA. OBALON VISUALLY INSPECTED THE BALLOON WITH LIGHT MICROSCOPY AND MATERIAL FATIGUE WAS OBSERVED. SCANNING ELECTRON MICROSCOPE (SEM) IMAGES WERE OBTAINED FOR THE DEFLATED BALLOON AND A BREACH WAS IDENTIFIED IN THE AREA OF THE MATERIAL FATIGUE. THE BREACH IN THE BALLOON IS THE LIKELY CAUSE FOR DEFLATION. A POTENTIAL ROOT CAUSE OF THE DEFLATION COULD BE MATERIAL FATIGUE RESULTING FROM A LOW BALLOON PRESSURE; HOWEVER, THE ACTUAL ROOT CAUSE REMAINS UNKNOWN. DEFLATION IS A KNOWN RISK, THE FREQUENCY OF BALLOON DEFLATIONS HAS NOT EXCEEDED THE FREQUENCY IDENTIFIED IN THE LABELING. OBALON'S LABELING ADDRESSES THE REPORTED EVENT WITH WARNINGS FOR MONITORING PATIENTS FOR DEFLATION SYMPTOMS. OBALON'S LABELING STATES, "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." AND "IT IS EXPECTED FOR PATIENTS TO EXPERIENCE SOME DEGREE OF NAUSEA, VOMITING, AND CRAMPING WITHIN THE FIRST WEEK AFTER EACH BALLOON ADMINISTRATION. SEVERE SYMPTOMS DURING THAT TIME OR NEW SYMPTOMS OCCURRING AFTER THE FIRST WEEK COULD INDICATE A PREMATURE BALLOON DEFLATION. A SUDDEN LOSS OF FULLNESS OR A SUDDEN INCREASE IN FEELINGS OF HUNGER MAY ALSO INDICATE A POTENTIAL BALLOON DEFLATION. IN THESE CIRCUMSTANCES, RADIOGRAPHIC IMAGING SHOULD BE CONSIDERED TO RULE OUT A POTENTIAL BALLOON DEFLATION. BALLOON VALVES ARE RADIOPAQUE AND THE OUTLINE OF AN INFLATED BALLOON WILL HAVE AN ELLIPTICAL OR CIRCULAR PERIMETER. IF ALL BALLOONS CANNOT BE VISUALIZED WITH A SINGLE X-RAY VIEW, A SECOND X-RAY VIEW SHOULD ALSO BE EVALUATED."

    Description of Event or Problem · 1

    A SINGLE DEFLATED BALLOON WAS IDENTIFIED AT A NORMALLY SCHEDULED ENDOSCOPIC REMOVAL IN A MALE PATIENT WITH A FIRST BALLOON PLACEMENT OF (B)(6) 2018, SECOND BALLOON PLACEMENT OF (B)(6) 2018, AND THIRD BALLOON PLACEMENT OF (B)(6) 2018. THE BALLOON WAS IDENTIFIED FREE FLOATING IN THE STOMACH WITH NO MIGRATION INTO THE LOWER INTESTINE DURING THE NON-EMERGENT, SCHEDULED ENDOSCOPY REMOVAL ON (B)(6) 2018. ALL BALLOONS WERE SUCCESSFULLY REMOVED BY ENDOSCOPY WITHOUT COMPLICATION AND ONLY THE DEFLATED BALLOON WAS RETURNED TO OBALON FOR INVESTIGATION. THERE WAS NO INJURY ASSOCIATED WITH THE DEFLATED BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021313 OBALON BALLOON SYSTEM INTRAGASTIC BALLOON LTI OBALON THERAPEUTICS, INC. 7410-0001 180425409

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR