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

Model Number	B-4800
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dehydration (1807); Nausea (1970); Vomiting (2144); Discomfort (2330)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a orbera intragastric balloon system was implanted on (b)(6) 2024.On (b)(6) 2024, the patient presented to the emergency department with nausea, vomiting, abdominal pain, and dehydration.The patient was admitted to the hospital and discharged (b)(6) 2024.On (b)(6) 2024, the patient presented to the emergency department with nausea and vomiting.The patient was admitted to the hospital where two (2) ct scans and a egd were performed.On (b)(6) 2024, the balloon was removed, and the patient discharged.The patient's condition was reported to be fully recovered.It was reported that methylene blue was used when filling the orbera balloon.However, according to the instructions for use (ifu) the igb is places in the stomach and filled with sterile saline.
Additional Manufacturer Narrative
Block h6: imdrf code f08: captures the reportable event of hospitalization.Imdrf code f2202: captures the reportable event of additional endoscopic procedure.Imdrf code f2303: captures the reportable event of medication required.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19558695
• Report Number: 3005099803-2024-02941
• Device Sequence Number: 14655646
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P140008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2025
• Device Model Number: B-4800
• Device Lot Number: AF05548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/18/2024
• Date Device Manufactured: 04/14/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 95 KG