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

Model Number	7600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The prepared dispenser pressure and balloon inflation pressures were recorded at placement and were within the labeled range.A potential root cause of the deflation could be material fatigue resulting from low balloon pressure, however the actual root cause remains unknown.The instruction for use contains the following warning: "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".The patient was not evaluated for a deflated balloon after reporting symptoms of nausea and vomiting to the prescribing physician.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.
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 had a scheduled removal on (b)(6) 2018 at a gi facility.The removing gi successfully removed two balloons which were discarded.The prescribing physician subsequently noted that the patient had three balloons implanted and that only two balloons were removed during preparation of the post-op visit scheduled for (b)(6) 2018.The patient confirmed that they had experienced a new onset of symptoms of nausea and stomach pain in approximately (b)(6) 2018 and saw a foreign object in their stool which could have been the balloon.The balloon that was passed in the stool was not retrieved.The patient had not previously reported passing the balloon to the prescribing physician but had reported symptoms of nausea of vomiting for several weeks which had resolved in (b)(6) 2018.X-ray imaging performed on (b)(6) 2018 confirmed that the balloon was not in the patient.The patient was doing well after the removal of the remaining implanted balloons with no issues post removal and the patient lost 27 pounds during the treatment.There was no serious injury due to the deflated balloon.

• 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: 7700299
• Report Number: 3009256831-2018-00422
• Device Sequence Number: 13722148
• Product Code: LTI
• UDI-Device Identifier: 00859810006067
• UDI-Public: (01)00859810006067
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: No Information
• Device Model Number: 7600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 78