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

Model Number	7500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The deflated balloon was the first balloon implanted of the three-balloon system and was implanted for a duration of 141 days.The balloon inflation pressures were not recorded at placement.The deflated balloon was not returned to obalon; however, the remaining two inflated balloons were returned for analysis.Obalon initiated a technical investigation and a third-party laboratory conducted culture analysis.The balloon volumes were within the expected volume specification and no material fatigue was observed during visual inspection with light microscopy.The culture analysis results on sample swabs from the balloons showed no detectable evidence of bacteria and the limited fungi identified are commonly identified in the gut flora and gastrointestinal tract of healthy individuals.A potential root cause of the deflation could be material fatigue resulting from 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.No serious injury was associated with the event.
Event or Problem Description
A female patient with a first balloon implantation date of (b)(6) 2017, second balloon placement of (b)(6) 2018, and third balloon placement of (b)(6) 2018 experienced a new onset of symptoms of nausea and stomach pain on approximately (b)(6) 2018.The patient went to ed while traveling on (b)(6) 2018 and during endoscopy, one balloon was identified as deflated in the stomach.The deflated balloon was successfully removed by endoscopy without complication and was discarded.The ed did not want to remove the inflated balloons so the remaining two inflated balloons were removed on (b)(6) 2018 by the prescribing physician and returned to obalon for investigation.There was no serious injury due to the deflated balloon.The patient was doing well after the removal with no issues post removal.The patient lost 22 pounds during the treatment from a starting bmi of (b)(6).

• 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: 7487560
• Report Number: 3009256831-2018-00236
• Device Sequence Number: 1717859
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036
• 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 Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: Physician
• Device Expiration Date: 03/12/2018
• Device Model Number: 7500
• Device Lot Number: 170313404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 103