BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBALON BALLOON SYSTEM

    MDR report key: 7088239 · Received December 6, 2017

    Report

    Report Number
    3009256831-2017-00254
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    September 24, 2017
    Report Date
    December 6, 2017
    Manufacturer
    OBALON THERAPEUTICS, INC.
    Product Code
    LTI
    UDI-DI
    00859810006036
    PMA / PMN Number
    P160001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INVESTIGATION IDENTIFIED A HOLE IN THE BALLOON; HOWEVER, SINCE THE BALLOON WAS NOT REPORTED AS DEFLATED, IT WAS ASSUMED THAT THE HOLE WAS DUE TO ENDOSCOPY TOOLS (PUNCTURE NEEDLE) AND NO OTHER REMARKABLE INFORMATION CAME AS A RESULT OF THE INVESTIGATION AND A PRODUCT DEFECT WAS NOT IDENTIFIED. ON NOVEMBER 10, 2017, OBALON RECEIVED ADDITIONAL INFORMATION THROUGH THE VOLUNTARY REGISTRY THAT THE BALLOON WAS NOT UNDERINFLATED, BUT RATHER, THE PHYSICIAN DESCRIBED IT AS DEFLATED. AS A RESULT OF THIS FEEDBACK, RE-ASSESSMENT/ADDITIONAL INVESTIGATION OF THE BALLOON WAS CONDUCTED. THE BALLOON IMPLANTATION MEDICAL RECORD INFORMATION WAS REQUESTED AND BALLOON INFLATION PRESSURES WERE RECORDED AS WITHIN EXPECTED RANGE. OBALON INITIATED AN ADDITIONAL TECHNICAL INVESTIGATION OF THE PRODUCT FAILURE INCLUDING AN ENGINEERING ANALYSIS AT OBALON AND A THIRD-PARTY LAB. SCANNING ELECTRON MICROSCOPE (SEM) AND OPTICAL MICROSCOPY IMAGES WERE OBTAINED AND THE BREACH IN THE BALLOON WAS IDENTIFIED AS THE LIKELY CAUSE FOR DEFLATION. THE IMAGING DATA INDICATED FATIGUE IN THE AREA OF THE BREACH. THERE WAS NO EVIDENCE OF MANUFACTURING OR BALLOON REMOVAL DAMAGE IN THE REGION OF THE BREACH. THE INITIAL INVESTIGATION SUGGESTS THAT THE PRELIMINARY ROOT CAUSE OF THE DEFLATION WAS LIKELY DUE MATERIAL FATIGUE RESULTING FROM LOW BALLOON PRESSURE, HOWEVER THE ROOT CAUSE OF THE LOW BALLOON PRESSURE IS UNKNOWN. AFTER OBTAINING THE ADDITIONAL INFORMATION ON NOVEMBER 10TH THAT THE BALLOON WAS DEFLATED WITH THE INVESTIGATION CONFIRMING THIS, OBALON REASSESSED AND UPDATED THE CONCLUSION THAT THE EVENT WAS REPORTABLE. DEFLATION IS A KNOWN RISK, WITH THE INCLUSION OF THIS EVENT 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.

    Description of Event or Problem · 1

    A FEMALE PATIENT WITH THREE BALLOONS IMPLANTED, FIRST BALLOON PLACED ON (B)(6) 2017, SECOND BALLOON PLACED ON (B)(6) 2017 AND THIRD BALLOON PLACED (B)(6) 2017, HAD A REMOVAL SCHEDULED FOR (B)(6) 2017. APPROXIMATELY 2 WEEKS PRIOR TO REMOVAL, THE PATIENT REPORTED A SUDDEN ONSET OF SYMPTOMS INCLUDING CRAMPING AND VOMITING. ON (B)(6) 2017, THE PHYSICIAN BROUGHT THE PATIENT IN FOR A FLUOROSCOPIC EVALUATION AND ALL THREE BALLOONS APPEARED INFLATED AND FLOATING AT THE TOP OF THE STOMACH. THE PATIENT REPORTED RESOLUTION OF SYMPTOMS SHORTLY THEREAFTER. THE BALLOONS WERE REMOVED PER THE SCHEDULED ENDOSCOPY APPOINTMENT ON (B)(6) 2017 WITHOUT ISSUE. IT WAS DOCUMENTED AND REPORTED TO OBALON THAT DURING THE REMOVAL ONE OF THE THREE BALLOONS WAS OBSERVED TO BE UNDERINFLATED. THE REPORTED BALLOON WAS RETURNED TO OBALON FOR INVESTIGATION. THE PATIENT LOST 21.4 POUNDS AND THERE WERE NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866664 OBALON BALLOON SYSTEM INTRAGASTIC BALLOON LTI OBALON THERAPEUTICS, INC. 7500 161213401 00859810006036

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR