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); Deflation Problem (1149); 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.

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 (b)(6) 2023.On (b)(6) 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 a1401 is being used to capture the reportable event of balloon deflated.Problem code f2202 is being used to capture the reportable event of endoscopic procedure.Block h10: investigation summary: with all the available information, boston scientific concludes that the reported event of balloon deflated is confirmed.Device analysis found the balloon was returned deflated with green coloration on the shell.There was a large hole on the shell and the hole had rounded edges and rolled inwards.It was reported that methylene blue was added to the orbera balloon when filling it.However, the orbera365 intragastric balloon system directions for use (ifu) states the igb is placed in the stomach and filled with sterile saline.Balloon deflated is known and documented in the labeling and all reasonable steps have been taken (including both short or long term known complications or adverse reactions).Based on all available information and analysis of the returned device, the most probable cause of this complaint is known inherent risk of device.Device history record review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the orbera365 intragastric balloon system was received for analysis.Visual inspection of the balloon noted the balloon was received deflated with green coloration on the shell and there was a large hole on the shell that had rounded edges and rolled inwards.Labeling review: a labeling review was performed and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu).It was reported that methylene blue was added to the orbera balloon when filling it.However, the orbera365 intragastric balloon system directions for use (ifu) states: the igb is placed in the stomach and filled with sterile saline.Balloon deflated is known and documented in the labeling and all reasonable steps have been taken (including both short or long term known complications or adverse reactions).Investigation conclusion: based on all available information and analysis of the returned device, the most probable root cause of this complaint is known inherent risk of device.Block h11: block h6 imdrf code a0402 has been corrected to imdrf code a1401 to capture the reportable event of balloon deflated.

• 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; 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: 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,Followup
• Report Date: 04/15/2024

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-50012
• Device Lot Number: AF05275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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