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

Model Number B-40800

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

Patient starting weight:82 kg.Patient event weight: 82 kg.

Event Description

It was reported to boston scientific corporation that an orbera balloon was implanted on (b)(6) 2023 with no complications.On (b)(6) 2023 the patient presented with pain.The patient underwent an endoscopy procedure on (b)(6) 2023 where it was found that the balloon was hyperinflated.The balloon was explanted.After puncturing the balloon with a needle, approximately 680ml of serum was aspirated with methylene blue.The balloon was seized with grasper forceps and removed under continuous traction with some difficulty.There were no reported patient complications following the removal, and it was reported that the patient is well.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.

• Brand Name: BIB INTRAGASTRIC BALLOON SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 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: 18590538
• MDR Text Key: 333899310
• Report Number: 3005099803-2024-00170
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2024

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
• Device Operator: Health Professional
• Device Model Number: B-40800
• Device Lot Number: AF05348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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: 82 KG