MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ORBERA365 INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number B-50012

Device Problems Deflation Problem (1149); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an orbera365 intragastric balloon system was implanted into the patient on (b)(6) 2023.After approximately 10 months, the patient reported weight gain and bluish urine.On (b)(6) 2024, an endoscopic procedure was performed and confirmed the balloon was largely deflated.The balloon was explanted.There were no patient complications as a result of this event.Note: it was reportable that methylene blue was used when filling the orbera balloon.However, according to the instructions for use (ifu), "the igb is placed in the stomach and filled with sterile saline.".

Manufacturer Narrative

Block h6: impact code f2202 captures the reportable event of additional endoscopic procedure.Device code a1401 captures the reportable event of deflation problem.

• Brand Name: ORBERA365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 120 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: 18619371
• MDR Text Key: 334258381
• Report Number: 3005099803-2024-00078
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B-50012
• Device Lot Number: AF05285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 100 KG