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

Model Number	B-4800
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of cancelled / rescheduled post sedation.
Event or Problem Description
It was reported to boston scientific than an orbera balloon was used for an intragastric balloon implant procedure on (b)(6) 2025.During the procedure, the physician noticed a torn sheath prior to pulling it out of the package.No extra balloon was on hand and the procedure was re-scheduled and successfully completed on (b)(6) 2025.No patient complications were reported as a result of the 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 MI 49512
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22121905
• Report Number: 3005099803-2025-02400
• Device Sequence Number: 17931469
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: (01)10811955020619(11)230227(17)250227(10)AF05451
• 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
• Report Date (Section B): 06/02/2025

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: 02/27/2025
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF05451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 02/27/2023
• 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
• Patient Age: 32 YR
• Patient Sex: Female