MAUDE Adverse Event Report: OBALON THERAPEUTICS, INC. OBALON BALLOON SYSTEM; INTRAGASTIC BALLOON

Model Number	7600-0001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Flatus (1865); Abdominal Distention (2601)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The balloon inflation pressures were recorded as within the pressure range at implantation.The first, second and third balloons were implanted for 280 days, 266 days and 161 days, respectively which is beyond the labeled 6 month use of the device therapy.A potential root cause of the deflation could have been material fatigue resulting from low balloon pressure, however the actual root cause remains unknown.Deflation is a known risk; the frequency of balloon deflations to date has not exceeded the frequency identified 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".
Event or Problem Description
A single balloon was found to be no longer located in the stomach during a scheduled overdue endoscopic removal on (b)(6) 2019 in a male patient with a first balloon placement of (b)(6) 2018, second balloon placement of (b)(6) 2018, and a third balloon placement of (b)(6) 2018.The two balloons found in the stomach were successfully removed by endoscopy without complication but were not returned to obalon for investigation.The patient did not report a new onset of symptoms to their prescribing physician, however after the removal the patient stated they had bloating and flatulence at unspecified dates.The patient was instructed by the prescribing physician after the balloon removal to receive an abdominal x-ray, however, to date it is unknown if the patient has received an x-ray.

• Brand Name: OBALON BALLOON SYSTEM
• Common Device Name: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• MDR Report Key: 8362437
• Report Number: 3009256831-2019-00035
• Device Sequence Number: 11271353
• Product Code: LTI
• UDI-Device Identifier: 00859810006067
• UDI-Public: (01)00859810006067
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7600-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 118