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	Nausea (1970); Vomiting (2144)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The balloon inflation pressures were not recorded at the time of administration.The root cause is unknown in particular since the deflated balloon was not returned for investigation.Deflation is a known risk and the frequency of balloon deflations to date has not exceeded the frequency included 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 endoscopic removal on (b)(6) 2019 in a patient with two balloons, first balloon placement of (b)(6) 2018 and second balloon placement of (b)(6) 2018.The remaining balloon located in the stomach was successfully removed by endoscopy without complication but was not returned for investigation.After the discovery of the missing balloon at removal, the patient nausea and vomiting during late november or early december that was not reported to the prescribing physician.The patient received an abdominal radiography on (b)(6) 2019 that showed no signs of a balloon located in the intestinal tract.

• 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: 8591810
• Report Number: 3009256831-2019-00168
• Device Sequence Number: 16717983
• Product Code: LTI
• UDI-Device Identifier: 00859810006067
• UDI-Public: (01)00859810006067
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/08/2019

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 Model Number: 7600-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 80