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

Model Number	PN7500
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), a female patient came for a second balloon placement procedure.The balloon capsule was swallowed and inflated uneventfully.However during the catheter retrieval process the catheter burst proximally from the patient's mouth, and distally from the catheter luer.This burst resulted in a breach in the closed loop gas pathway that leads to balloon depressurization leaving an underinflated balloon in the body.Representatives from obalon recommended that the balloon be removed endoscopically according to the labeling.The balloon was not removed.The breached catheter was returned to obalon for investigation.The catheter was sent for sem and the root cause of the burst was due to a bite impression located distally from the burst.The resulting investigation concluded that the balloon does not have sufficient pressurization and should be removed in order to maintain patient safety and prevent serious injury.Radiographs performed on (b)(6) showed that the balloon was still in the fundic region.To date, the balloon has not been removed and the manufacturer continues to recommend balloon removal.Per the labeling, an underinflated balloon can lead to a full balloon deflation resulting in an increased potential for migration/obstruction leading to serious injury.Labeling also indicates that the balloon pressure cannot be determined using radiography alone.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.
Additional Manufacturer Narrative
This report is an update to the previous report that indicates that the patient has returned for an endoscopic removal.The procedure was successful without any clinical sequelae.Both balloons were still in the stomach, in the fundic region with no symptoms of migration or obstruction.The balloons were returned for further examination.The balloons were normal with the exception of the expected holes and grasper marks from the removal procedure.The suspect balloon from the adverse event report had notable crosshatch which is a precursor to premature fatigue due to the low inflation pressures of the balloon.The balloon did not otherwise have any breaches or leaks that would have caused deflation after being ejected from the catheter.
Event or Problem Description
On (b)(6) 2017, a female patient came for a second balloon placement procedure.The balloon capsule was swallowed and inflated uneventfully.However during the catheter retrieval process the catheter burst proximally from the patient's mouth, and distally from the catheter luer.This burst resulted in a breach in the closed loop gas pathway that leads to balloon depressurization leaving an underinflated balloon in the body.Representatives from obalon recommended that the balloon be removed endoscopically according to the labeling.The balloon was not removed.The breached catheter was returned to obalon for investigation.The catheter was sent for sem and the root cause of the burst was due to a bite impression located distally from the burst.The resulting investigation concluded that the balloon does not have sufficient pressurization and should be removed in order to maintain patient safety and prevent serious injury.Radiographs performed showed that the balloon was still in the fundic region.This report is an update to the previous report that indicates that the patient has returned for an endoscopic removal.The procedure was successful without any clinical sequelae.Both balloons were still in the stomach, in the fundic region with no symptoms of migration or obstruction.The balloons were returned for further examination.The balloons were normal with the exception of the expected holes and grasper marks from the removal procedure.The suspect balloon from the adverse event report had notable crosshatch which is a precursor to premature fatigue due to the low inflation pressures of the balloon.The balloon did not otherwise have any breaches or leaks that would have caused deflation after being ejected from the catheter.Per the labeling, an underinflated balloon can lead to a full balloon deflation resulting in an increased potential for migration/obstruction leading to serious injury.Labeling also indicates that the balloon pressure cannot be determined using radiography alone.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.

• Brand Name: OBALON BALLOON SYSTEM
• Common Device Name: INTRAGASTRIC BALLOON
• Manufacturer (Section D): OBALON THERAPEUTICS, INC; 5421 avenida encinas; suite f; carlsbad CA 92008
• MDR Report Key: 6408502
• Report Number: 3009256831-2017-00014
• Device Sequence Number: 36377
• Product Code: LTI
• UDI-Device Identifier: 00859810006036
• UDI-Public: (01)00859810006036(17)171218(10)161219403
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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: Health Professional
• Device Expiration Date: 12/18/2018
• Device Model Number: PN7500
• Device Lot Number: 161219403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1