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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Nausea (1970); Perforation (2001); Vomiting (2144); Ulcer (2274)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

The balloons were returned to obalon for investigation and sent to a third-party laboratory for culture analysis.The results showed colony forming units of bacteria normally found in the digestive tract or are human commensal.Additionally fungi commonly found in the gut flora were detected.Obalon visually inspected the balloons with light microscopy and no material fatigue was observed.Balloon volumes were within the expected volume specification.The patient's medical records were reviewed by obalon's medical reviewer and determined that despite the ulcer being described as chronic, exact timing of the start of the ulcer (pre or post balloon administration) could not be determined.The patient did have the necessary pre-balloon administration barium esophagram, but this was not sufficient to evaluate the stomach to rule out gastric ulcer.Moreover, based on further patient evaluation, symptoms were not communicated to the managing physician and evidence from the medication reconciliation at the september hospitalization, suggests the patient was not taking a proton pump inhibitor as prescribed.Per the event description, the ct scan conducted during the initial hospitalization from which complications associated with the balloon were ruled out and had a notation of no significant findings in the stomach.However, the second hospitalization showed an obvious perforation with air and fluid outside the stomach.The scans from both visits were subsequently reviewed by obalon's consulting board-certified radiologist who identified a subtle area of abnormality along the lesser curvature with inflammatory infiltration in the peri-gastric fat on the first visit's ct scan.He also noted that the antrum of the stomach was concentrically thickening and the mucosa was enhancing which may have been reactive to the abnormality at the lesser curvature.Furthermore, he noted that a pre-existing lesion could not be excluded.The area of abnormality on the first scan matched the location on the second visit scan that showed an obvious perforation with air and fluid outside of the stomach.Ultimately obalon's consulting radiologist would have considered the first scan abnormal in the area of the stomach and would have recommended further evaluation due to concern for a pending rupture based upon the abnormality noted.In his opinion, had he reviewed the first scan, he would have spoken with the referring physician and encouraged additional evaluation in this regard and suggested endoscopy as the next step.Balloon administration records were reviewed and all balloon inflation pressures were within range and there were no administration issues documented.During the pre-op assessment, h.Pylori testing was negative and a small hiatal hernia (1.9 x 1.9 cm) was confirmed by radiology.The root cause for the stomach perforation is as a result of the untreated ulcer; although the prescribing physician and gastroenterologist did not think that the balloons were the direct or primary contributing factor.Additionally, ulceration was not ruled out during the patient's first hospitalization such that the perforation could have been avoided.Obalon's labeling includes warnings for monitoring patients for symptoms.Per the labeling, each patient should be monitored closely during the entire device therapy period in order to detect the development of possible complications.Patients should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration, esophageal injury or perforation, gastric perforation, and other possible complications that could occur, and should be advised to contact their physician if these symptoms worsen over time or persist for more than 24 hours.Additionally, the labeling includes ppi information and a contraindication for patients unwilling to take ppis.Per the labeling, "balloon use requires the concurrent use of proton pump inhibitors for the duration of implantation." and "contraindication: patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.".

Event Description

A female patient with first balloon administration on (b)(6) 2018, second balloon administration on (b)(6) 2018, and third balloon administration on (b)(6) 2018, was evaluated by their prescribing physician on (b)(6) 2018 due to reported nausea and vomiting over two weeks.An x-ray showed intact balloons with normal placement and there were no signs of gastric perforation or obstruction.The patient denied abdominal pain, bowel or urinary changes, and hematemesis.The patient admitted to not drinking enough fluid except for sprite which seemed to help with the nausea.The patient requested suppositories for nausea and was given a prescription.During this visit, the patient also reported she was undergoing lab work for other health issues by her primary care physician but did not provide any additional information.The patient was counseled to go to the er if the symptoms were persistent or worsening.The patient presented to an emergency room on (b)(6) 2018 and was admitted with symptoms of vomiting for 3 weeks, shortness of breath, dizziness.The patient was examined by ct-scan with no significant findings.Hypokalemia and urinary sepsis were diagnosed and the patient discharged on (b)(6) 2018.The patient did not report taking prescribed ppis at this visit but reported taking other non-balloon related medications.Ppis were also not listed on the discharge medication list.On (b)(6) 2018 the patient presented to an emergency room for chest and shoulder pain (left) which radiated into the jaw.Gastric perforation was found by a second ct scan.The patient was transferred to another hospital at the request of the treating physician's partnering gastroenterologist familiar with the obalon balloon system.The balloons were removed endoscopically.What was described by the gastroenterologist as a small stomach perforation found within a 30 mm cratered ulcer along the lesser curvature of the stomach, with portions which appeared to be chronic.There were also signs of esophagitis most likely as a result of vomiting.The stomach perforation was surgically repaired the next day by gastric wedge resection on (b)(6) 2018.Pathology results were negative for evidence of intestinal metaplasia, negative for evidence of neoplasm or infiltrates, h pylori negative, and the residual gastric mucosa adjacent to the area of ulceration exhibits nonspecific superficial chronic inflammation.The patient was discharged on (b)(6) 2018 in stable condition with no sequelae.The patient self-reported that they were compliant with the prescribed proton pump inhibitors when asked by the treating physician; however did not report use at the (b)(6) hospitalization.The patient had a medical history of hypertension and high cholesterol, but a prior history of daily aspirin use for cardiac protection that had stopped years ago.The prescribing physician visited the patient in the hospital and during the visit the patient stated they started having nausea several weeks prior but did not report these symptoms at the risk of terminating the balloon treatment as they wanted to continue with the weight loss progress.

Manufacturer Narrative

Obtained operative report medical record.

• Brand Name: OBALON BALLOON SYSTEM
• Type of Device: INTRAGASTRIC 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: 8035659
• MDR Text Key: 126070459
• Report Number: 3009256831-2018-00671
• Device Sequence Number: 1
• Product Code: LTI
• 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,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: 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: 62 YR
• Patient Weight: 84