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

Model Number	7600-0001
Medical Device Problem Codes	Material Rupture (1546); Material Perforation (2205)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inflation catheter was returned to obalon for inspection, however the balloon was not returned.An engineering investigation was performed and the inflation catheter was visually inspected with optical microscopy and scanning electron microscopy (sem) and a breach (material rupture) was identified approximately 1 inch from the distal end.The breach could have potentially been caused by a patient bite to the catheter or catheter anomaly, however the root cause of breach is unknown.The balloon was removed endoscopically in accordance with the labeling and no serious injury was reported with this event.Per the labeling, do not rely solely on the gauge measurement for confirmation of placement in the stomach.You must confirm all pressure measurements with x-ray or fluoroscopy verification.During inflation, if there is indication of inflation in a constrained space (by pressure readings or patient symptoms), shut off the gas flow by closing the green valve, detach the catheter and evacuate the gas from the balloon with a 60 cc syringe.Proceed to the troubleshooting section.
Event or Problem Description
A male patient swallowed the balloon capsule and the prescribing physician stated that verification that the balloon was in the stomach was difficult to confirm.The room used for visualization was not the physician's typical fluoroscopy room and the equipment settings seemed incorrect.The physician thought she could see the valve but was uncertain.She initiated the pre-pulse stage of inflation and the pre-pulse pressure was hovering at 22 kpa but then the pre-pulse pressure jumped down to 5 kpa.The physician evacuated the balloon pressure with the 60 cc syringe and apple sauce was used to facilitate esophageal transit.The visualization of the valve was still difficult but she decided to proceed with inflation but instructed the patient to immediately notify her of any discomfort.Balloon inflation was initiated with the physician holding the ezfill dispenser green valve and asked the patient for any signs of discomfort.When the patient felt and communicated symptoms of pressure, the green valve was closed to stop the balloon inflation.The balloon was removed by endoscopy and confirmed in the esophagus and superficial mucosal damage was noted.Patient remains stable with no sequelae.

• Brand Name: OBALON BALLOON SYSTEM
• Common Device Name: INTRAGASTIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC.; 5421 avendia encinas; suite f; carlsbad CA 92008
• MDR Report Key: 7501369
• Report Number: 3009256831-2018-00231
• Device Sequence Number: 11204734
• Product Code: LTI
• UDI-Device Identifier: 00859810006067
• UDI-Public: (01)00859810006067
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: 160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/08/2018
• Device Model Number: 7600-0001
• Device Lot Number: 171109406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1