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

Model Number 7500-0001

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Obstruction/Occlusion (2422)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

The deflated balloon was the first balloon implanted of the three balloon system and was implanted for a duration over 242 days which is beyond the labeled 6 months use.The balloon inflation pressures at implant were requested but not provided; however, were reported to be within the labeled range.Obalon initiated a technical investigation of the product failure including analysis at obalon on the returned deflated balloon.The balloon volume was within the expected specification.Obalon visually inspected the balloons with light microscopy and material fatigue was observed.Obalon visually inspected the balloon with light microscopy and scanning electron microscopy (sem) and material fatigue was observed on 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 and the increased risk of deflation is communicated in the labeling with use of the product beyond 6-months.Obalon's labeling states: "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 radiography 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." obalon will update labeling with a special pma supplement - changes being effected to update the balloon deflation rate (migration that lead to a bowel obstruction requiring surgery to remove) and review labeling to determine if additional language is required to ensure patients and physicians understand the importance of balloon removal at 6 months.

Event Description

A male patient with a first balloon placement of (b)(6) 2018, second balloon placement of (b)(6) 2018, and third balloon placement of (b)(6) 2018 was scheduled for balloon removal in (b)(6) 2018 but cancelled four times due to personal travel.On (b)(6) 2018 the patient contacted their prescribing physician office to reschedule the balloon removal and reported a new onset of symptoms of nausea related to heartburn.Balloon removal was scheduled for (b)(6) 2018.On (b)(6) 2018 the patient was admitted to the ed due to a balloon deflation with migration into the jejunum causing a functional obstruction.The patient had been experiencing nausea, an inability to tolerate po intake, and abdominal pain for the past week.The patient had experienced 2-3 episodes of vomiting.The patient was transferred to a second er at the request of the obalon prescribing physician so that the patient could be under their direct care.Two inflated balloons were successfully removed from the stomach by endoscopy on (b)(6) 2018 but were discarded by the hospital and not returned to obalon; however, obalon had requested the return of all balloons prior to the endoscopic removal for product evaluation.On (b)(6) 2018, x-ray imaging found dilated loops of small bowel; however, obstruction could not be excluded, and there was oral contrast in the colon with no gross free air.Radiology indicated the device might be in the colon or small bowel.Patient symptoms subsided and the patient was discharged in stable condition on (b)(6) 2018.The patient returned to the ed on (b)(6) 2018 with shortness of breath, worsening fatigue, nausea, vomiting, and no bowel movement since the (b)(6) discharge.Further ct imaging was conducted and identified foreign material (deflated balloon) within a segment of the mid to distal small bowel, likely the site of transition for the small bowel obstruction.On (b)(6) 2018 the balloon was successfully removed with an exploratory laparotomy, "enerotomy", and removal of foreign body (balloon) with repair.The balloon was returned to obalon for investigation.

• Brand Name: OBALON BALLOON SYSTEM
• Type of Device: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• Manufacturer (Section G): OBALON THERAPEUTICS, INC.; 5421 avenida encinas; suite f; carlsbad CA 92008
• Manufacturer Contact: amy vandenberg ; 5421 avendia encinas; suite f; carlsbad, CA 92008 ; 7607956551
• MDR Report Key: 8116576
• MDR Text Key: 128790841
• Report Number: 3009256831-2018-00741
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: 00859810006036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2018
• Device Model Number: 7500-0001
• Device Lot Number: 170624401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 109