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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

Block a4: patient initial weight was 76kg patient's weight at the time of the event 72kg.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.

Event Description

It was reported to boston scientific that a bib intragastric balloon system was implanted into the patient on (b)(6) 2023.On november 20, 2023, imaging was done and confirmed the balloon had hyperinflated.The balloon was explanted on (b)(6) 2023 and another balloon was implanted.There were no patient complications reported as a result of this event.The patient' starting weight was 76 kg and the patient's weight at the time of the event was 72kg.

Manufacturer Narrative

Block a4: patient initial weight was 76kg patient's weight at the time of the event 72kg.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.Block h11: blocks b5 and d6b have been updated based on corrected information received on 29jan2024.

Event Description

It was reported to boston scientific that a bib intragastric balloon system was implanted into the patient on (b)(6) 2023.On november 20, 2023, imaging was done and confirmed the balloon had hyperinflated.The balloon was explanted on (b)(6) 2023 and another balloon was implanted.There were no patient complications reported as a result of this event.The patient's starting weight was 76 kg and the patient's weight at the time of the event was 72kg.

• 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 78744
• 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: 18527604
• MDR Text Key: 333049011
• Report Number: 3005099803-2024-00062
• 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,Followup
• Report Date: 02/27/2024

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: 01/17/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/27/2024
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 72 KG