MAUDE Adverse Event Report: APOLLO ENDOSURGERY 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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

Block h6 imdrf f2202: captures the reportable event of additional endoscopic procedure.Imdf a0402: captures the reportable event of balloon burst.

Event Description

It was reported to boston scientific corporation that an orbera365 intragastric balloon system was used on an intragastric balloon placement procedure used to treat obesity performed on (b)(6) 2023.After 7 months of having the balloon placed, the patient noticed having blue urine on (b)(6) 2023.A balloon rupture is presumed, and an endoscopic procedure was performed to confirm the malfunction.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 f2202: captures the reportable event of additional endoscopic procedure.Imdf a0402: captures the reportable event of balloon burst.Correction: block h6 device code has been corrected to device code.A1401 deflation problem, which is also reportable.

Event Description

It was reported to boston scientific corporation that an orbera 365 intragastric balloon system was used on an intragastric balloon placement procedure used to treat obesity performed on (b)(6) 2023.After 7 months of having the balloon placed, the patient noticed having blue urine on (b)(6) 2023.A balloon rupture is presumed and an endoscopic revision was also performed on (b)(6) 2023 which confirmed the event.

• Brand Name: ORBERA365 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; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18702044
• MDR Text Key: 335349080
• Report Number: 3005099803-2024-00499
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 102 KG