MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number	B-4800
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orbera intragastric balloon system was used during an implant procedure on (b)(6) 2025.During the procedure, there was a leak in the balloon.The balloon was removed, and the procedure was cancelled.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6 imdrf code f1001 is being used to capture the reportable event of procedure cancelled post sedation/sedation unknown.
Additional Manufacturer Narrative
Block h6 imdrf code f1001 is being used to capture the reportable event of procedure cancelled post sedation/sedation unknown.Block h2: correction.Block a6: updated.Block h2: device evaluation.Block h11.The returned orbera intragastric balloon system was analyzed.The reported event of device fluid leak was confirmed.A visual inspection and media analysis was performed.The device was returned with the fill tube, which was detached from the balloon.In the media analysis, it can be observed the device label information with the batch and upn number.However, it is not possible identify the device from the photo.There is no evidence the device was improperly used per the instructions for use (ifu), and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on all gathered information, the probable cause selected is adverse event related to procedure, because it was observed that the fill tube was detached from the balloon.This detachment could have compromised the fluid pathway, resulting in leakage of the inflation fluid from the balloon.Therefore, the fill tube detachment is considered the most probable contributor to the observed device fluid leak during the procedure, supporting the conclusion that the event was procedure related.Most likely procedural factors as handling of the device and the technique used by the physician (force applied), could have resulted in the damages encountered in the device.For the event cancelled/rescheduled - post sedation/sedation unknow, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.For this reason, will be classified as cause not established.All compiled information on this investigation determines that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an orbera intragastric balloon system was used during an implant procedure on (b)(6) 2025.During the procedure, there was a leak in the balloon.The balloon was removed, and the procedure was cancelled.No patient complications were reported as a result of this event.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Common Device Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23883270
• Report Number: 3005099803-2025-06860
• Device Sequence Number: 14620568
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: (01)10811955020619(11)250514(17)270514(10)AF06639
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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 Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF06639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: Black Or African American