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

Model Number B-40800

Device Problem Inflation Problem (1310)

Patient Problems Abdominal Pain (1685); Nausea (1970)

Event Date 10/31/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an orbera bib intragastric balloon system was implanted on (b)(6) 2023.The patient experienced nausea and abdominal pain for 30 days with progressive worsening.The patient had an x-ray image that showed hyperinflation of the balloon with air representing just under 2/3 of the balloon's volume.The balloon was explanted on (b)(6) 2023.No other treatment was required for this event.The patient's starting weight was 92 kg and the patient's weight at the time it was explanted was 81 kg.It was reported that the patient had complied with diet and lifestyle requirements.

Manufacturer Narrative

Block h6: impact code f2202 captures the reportable event endoscopic procedure.Impact code f2203 captures the reportable event imaging required.Device code a1406 captures the reportable event of hyperinflation.

• 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: 18522344
• MDR Text Key: 332959522
• Report Number: 3005099803-2024-00061
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140008
• 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: 01/16/2024

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: AF05391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2023
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 81 KG