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); Sleep Dysfunction (2517); No Information (3190)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

The balloon inflation pressures were recorded as within the pressure range at implantation.The first and second balloons were implanted for approximately 355 days and 329 days, respectively.A potential root cause of the deflation could have been material fatigue resulting from low balloon pressure due to use of the device beyond 6 months, however the actual root cause remains unknown.Deflation is a known risk; the frequency of balloon deflations to date has not exceeded the frequency identified 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 Description

On (b)(6) 2019, the spouse of a patient with two balloons implanted called to cancel a scheduled overdue endoscopic balloon removal for (b)(6) 2019.It was reported that a deflated balloon was identified and the balloons had been removed.The balloons were implanted greater than the labeled 6 months use with a first balloon placement of (b)(6) 2018 and second balloon placement of (b)(6) 2018.The balloons were not returned to obalon for investigation.The patient was previously identified by the prescribing physician's site as being overdue for their balloon removal and stated that the patient had been unresponsive to phone calls and emails.On (b)(6) 2018, the patient stated to the prescribing physician's office that they wanted to leave the balloons in until after an event in (b)(6).Obalon recommended that the balloons be removed as soon as possible due to the overdue removal date and potential risk of deflation.The patient had previously been contacted by the prescribing physician's office with emails, voicemail's, and certified and non-certified letters sent on (b)(6) 2018 regarding the patient being overdue for balloon removal.The patient contacted a different physician on (b)(6) 2019 and was subsequently scheduled for removal on (b)(6) 2019 after a same-day consultation.

Manufacturer Narrative

This supplemental report is being provided due to additional information obtained.The first and second balloons were implanted for approximately 353 days and 327 days, respectively, which is beyond the labeled balloon therapy of 6-month use.Originally the report noted that the balloons deflated, but it was unknown the result of the deflation.On (b)(6) 2019, the patient experienced symptoms of nausea, vomiting, and diarrhea for over a week.On (b)(6) 2019, the patient experienced severe pain as well as difficulty walking and sleeping.The patient had two balloons surgically removed on (b)(6) 2019 after being admitted to a hospital ed.The ed physician identified a single deflated balloon that migrated into the small bowel with obstruction and perforation.The deflated balloon was removed by laparotomy and a resection of the small bowel was performed.One balloon remained inflated in the stomach which the ed physician removed by gastrotomy in the mid body portion of the stomach due to the risk of an additional obstruction and nutrition needed for the patient during recovery.The patient was discharged on (b)(6) 2019.On (b)(6) 2019 the patient underwent a second surgery which consisted to repair a hernia with a mesh of a hypertrophic scar from the surgery performed on (b)(6) 2019.

• Brand Name: OBALON BALLOON SYSTEM
• Type of Device: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• MDR Report Key: 8362522
• MDR Text Key: 139837349
• Report Number: 3009256831-2019-00034
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036
• Combination Product (y/n): N
• PMA/PMN Number: P160001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

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: 04/27/2018
• Device Model Number: 7500-0001
• Device Lot Number: 170428404
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 40 YR