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

Model Number B-40800

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problems Gastritis (1874); Unspecified Tissue Injury (4559)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf patient code e1012: captures the reportable event of gastritis.Imdrf impact code f1001: captures the reportable event of absence of treatment.Imdrf impact code f08: captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f23: captures the reportable event of unexpected medical intervention.

Event Description

It was reported to boston scientific corporation that an orbera intragastric balloon system was used during implantation procedure on (b)(6) 2024.During the procedure the balloon began to leak.The patient was intubated as a precautionary measure to reduce the risk of aspiration.A second orbera intragastric balloon implant was attempted to use during same procedure however this balloon also leaked.The procedure was cancelled as a result of these events.The patient was admitted to the hospital as a precaution due to the extended procedure and acute gastritis due to mechanical irritation in the procedure.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 placed in the stomach and filled with sterile saline.

Manufacturer Narrative

Block h6: imdrf impact code f1001: captures the reportable event of absence of treatment.Imdrf impact code f08: captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f23: captures the reportable event of unexpected medical intervention.Correction: section h2, h6 and h10 based on additional information received 17mar2024.

Event Description

It was reported to boston scientific corporation that an orbera intragastric balloon system was used during implantation procedure on (b)(6) 2024.During the procedure the balloon began to leak.The patient was intubated as a precautionary measure to reduce the risk of aspiration.A second orbera intragastric balloon implant was attempted to use during same procedure however this balloon also leaked.The procedure was cancelled as a result of these events.Patient was admitted to the hospital as a precaution due to extended procedure acute gastritis due to mechanical irritation in the procedure.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 placed in the stomach and filled with sterile saline.Device is expected to be returned.

Manufacturer Narrative

Block h6: imdrf impact code f1001: captures the reportable event of absence of treatment.Imdrf impact code f08: captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f23: captures the reportable event of unexpected medical intervention.Block h6: imdrf patient code a150207: captures the reportable event of difficult to remove.Imdrf patient code e1012: captures the reportable event of gastritis.Imdrf impact code f2303: captures the reportable event of medication required.Investigation summary the reported event of balloon leak was confirmed.Although the bib intragastric balloon system was not returned, video evidence provided confirmed the balloon leaked a blue solution during filling.Risk review: a risk review of the orbera was completed and confirmed that the event of balloon device difficult to remove, catheter detachment of device or device component, device fluid leak, user error, medication required, gastritis, tissue damage, cancelled/rescheduled - post sedation/sedation unknown, hospitalization or prolonged hospitalization and intubation were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Device history record (dhr) review it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Instructions for use (ifu)/label review a labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label.It was reported 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.Additionally, it was confirmed that the following adverse events are anticipated in the ifu: gastritis, tissue damage, hospitalization or prolonged hospitalization and intubation.Investigation conclusion the product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event it is concluded as cause not established.Based on all available information, the most probably root cause assigned is cause not established.

Event Description

It was reported to boston scientific corporation that an orbera intragastric balloon (igb) system was used during implantation procedure on (b)(6) 2024.During the procedure the balloon was filled to 150mm, the catheter detached from the balloon, and the balloon began to leak.The patient was intubated as a precautionary measure to reduce the risk of aspiration, even though the physician was using the scope's suction.The physician deflated the balloon by endoscopic needle, however, there was difficulty removing the balloon from the patient's stomach.A second orbera intragastric balloon implant was attempted to be used during the same procedure, however, the same issues occurred.The procedure was cancelled as a result of these events.Patient was admitted to the hospital for 24-hour monitoring of acute gastritis due to mechanical irritation during the balloon removal attempts.While admitted, the patient received a protein pump inhibitor (ppi) infusion.After discharge, the patient remained on oral ppi meds for two weeks.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 placed in the stomach and filled with sterile saline.The devices have been disposed.

• Brand Name: BIB INTRAGASTRIC BALLOON SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY; 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: 18978970
• MDR Text Key: 338606855
• Report Number: 3005099803-2024-01256
• 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,Followup,Followup
• Report Date: 05/22/2024

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: AF05170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/17/2024; 04/29/2024
• Supplement Dates FDA Received: 04/11/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 138 KG