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

Model Number	7500-0001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Ulcer (2274)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The balloon therapy was beyond the labeled 6 month use.Obalon initiated a technical investigation of the product failure including an engineering analysis of the returned balloons.All balloon volumes were within the expected volume specification.The balloons were visually inspected with light microscopy and material fatigue was only observed on the deflated balloon.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.Deflation is a known risk, the frequency of balloon deflations has not exceeded the frequency identified in the labeling for on-label use.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." "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." "the risk of balloon deflation is significantly higher with balloons that are left longer than 6 months.".
Event or Problem Description
A patient with a first balloon placement in (b)(6) or (b)(6) 2018 presented to an ed on (b)(6) 2019 with severe nausea, vomiting, abdominal pain and intolerance to oral intake that began four days prior.During the endoscopic removal procedure on (b)(6) 2019, two balloons were found inflated in the stomach and one balloon was identified as deflated in the pylorus extending into the duodenal bulb causing a partial luminal obstruction.Two 10 mm clean based cratered ulcers were found in the antrum and pylorus, and multiple clean based ulcers were found in the duodenal bulb.All balloons were successfully removed by endoscopy and were returned for investigation.

• 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: 8662962
• Report Number: 3009256831-2019-00195
• Device Sequence Number: 19378643
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2018
• Device Model Number: 7500-0001
• Device Lot Number: 170428404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR