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

Model Number B-50012

Device Problems Burst Container or Vessel (1074); Use of Device Problem (1670)

Patient Problem Vomiting (2144)

Event Date 12/26/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an orbera365 intragastric balloon system was used on an intragastric balloon placement procedure performed on march 23, 2023.On december 26, 2023, the patient vomited blue-colored vomit and had green-colored urine.Upon confirmation by an endoscopic procedure, the deflated balloon was explanted.Note: 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.

Manufacturer Narrative

Block a4: patient's start weight: 73 kg.Patient's weight at time of event: 61 kg.Block h6: problem code a0402 is being used to capture the reportable event of balloon burst.Problem code f2202 is being used to capture the reportable event of endoscopic procedure.

• Brand Name: ORBERA365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of texas hwy; 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: 18545072
• MDR Text Key: 333268059
• Report Number: 3005099803-2023-07189
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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: AF05275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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: Female
• Patient Weight: 61 KG