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

Device Problem Off-Label Use (1494)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Nausea (1970); Vomiting (2144); Ulcer (2274)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Obalon's international and us labeling addresses the reported event with warnings for monitoring patients for ulcer symptoms, instructing patients regarding symptoms of ulceration, listing ulcers as a known adverse reaction, instructions that balloon use requires the concurrent use of proton pump inhibitors for the duration of use, and that balloons must be removed from the patient after six months after the initial balloon placement or sooner.Peptic ulcer disease is a known risk and the event has not exceeded the frequency identified in the labeling.Obalon's estimated ulceration rate in the (b)(6) study was 0.9%.The obalon trained gastroenterologist concluded that patient non-compliance with proton pump inhibitors during the extended balloon use was most likely what contributed to the event.Obalon has requested the hospital medical records but has not received records to date.

Event Description

A (b)(6) female patient from (b)(6) had two six-month balloons administered there on (b)(6) 2018.She moved to (b)(6) in (b)(6) 2018.She presented to a us outpatient office on (b)(6) 2018 with stomach pain, nausea, vomiting, and diarrhea for 5 days and was diagnosed with viral gastroenteritis based on history and sent home.She presented to an ed in (b)(6) with complaints of continued left sided abdominal pain, cramping, nausea, and vomiting on (b)(6) 2018.Work-up for pelvic causes was pursued and pelvic ultrasound (us) was normal.Labs including cbc, cmp, lipase were normal.The patient told the ed she had intragastric balloons in place, but a call was not made to gi.The ed put a referral in for an outpatient gi clinic visit.On (b)(6) 2018 the scheduling team noticed the abdominal pain for the patient with a history of intragastric balloons and notified an obalon trained gastroenterologist.The patient was told to go back to the ed, the ed was advised to get imaging to rule out small bowel obstruction and repeat lab testing.Ct imaging on (b)(6) 2018 at 22:20 demonstrated two gas filled balloons in the stomach and gastric antral wall thickening, but no evidence of free air.On (b)(6) 2018 an obalon trained gastroenterologist at the hospital endoscopically removed two fully inflated balloons from the stomach.A 15 mm cratered clean-based ulcer was identified during endoscopy as well as la grade b esophagitis.Upon further questioning, the patient reported not taking ppi therapy for at least 3 months because she had no symptoms with the balloons and did not think she needed it.The patient stated that she knew her balloons were past due for removal but did not want to remove them because she was doing well and had lost weight.The patient was hospitalized for one night for observation and discharged the next day on (b)(6) 2018.Follow up included ppi and sucralfate (carafate).The balloons were discarded by the hospital and therefore were not returned to obalon for investigation.Patient remains stable with no sequelae and will follow-up with the obalon trained gastroenterologist for repeat egd in (b)(6) 2019.

Manufacturer Narrative

In (b)(6) 2019, the treating physician performed the scheduled follow up endoscopy on the patient and the ulcer was completely healed.The physician noted that the patient still had grade a esophagitis and a 2 cm hiatal hernia, therefore they believe the esophagitis was pre-existing and may have had some contributing conditions.A tissue biopsy was taken and the patient was positive for helicobacter pylori.Untreated helicobacter pylori infection is contraindicated with use of the obalon balloon system.

• 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 avenida encinas; suite f; carlsbad, CA 92008 ; 7607956551
• MDR Report Key: 8116575
• MDR Text Key: 128788985
• Report Number: 3009256831-2018-00785
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 160001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 42 YR