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

Model Number	7600-0001
Medical Device Problem Codes	Leak/Splash (1354); Migration (4003)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	01/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The balloon therapy was beyond the labeled 6 month use and was administered using the ezfill dispenser.Deflation is a known risk, the frequency of balloon deflations has not exceeded the frequency identified in the labeling for on-label use.The first, second, and third balloons were implanted for approximately 526 days, 512 days, and 484 days, respectively, which are beyond the labeled 6 month use.The root cause is unknown in particular since the deflated balloon was not returned for investigation.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." (b)(4).
Event or Problem Description
A single balloon migrated into the small bowel causing a perforation and required surgical repair in a patient with three balloons placed.The patient's first balloon was placed approximately 1.5 years prior on (b)(6) 2018, the second balloon was placed on (b)(6) 2018, and the third balloon was placed on (b)(6) 2018.The physician had contacted the patient multiple times to attempt scheduling the removal of the balloons.The patient began experiencing symptoms of abdominal pain and presented to the emergency department on (b)(6) 2020 and a ct scan showed a balloon in the small bowel.Two inflated balloons in the stomach were removed endoscopically on (b)(6) 2020 and the migrated balloon was in the mid jejunum and it was felt that this balloon would likely pass.The third balloon remained in the small intestine and during the hospitalization the patient developed worsening abdominal pain and a ct scan showed a small bowel perforation with intra-abdominal free air.The migrated balloon was surgically removed and a small bowel resection was performed on (b)(6) 2020.The patient was hospitalized a total of nine days and was stable after discharge.The balloons were not returned to obalon 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
• MDR Report Key: 9696626
• Report Number: 3009256831-2020-00001
• Device Sequence Number: 11198144
• Product Code: LTI
• UDI-Device Identifier: 00859810006067
• UDI-Public: 00859810006067
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2018
• Device Model Number: 7600-0001
• Device Lot Number: 171122406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 87