MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA365 INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number AF05105

Device Problems Deflation Problem (1149); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an orbera365 intragastric balloon system was implanted on (b)(6) 2022 for weight loss.The patient noticed that her urine had changed color.She had an endoscopy procedure on (b)(6) 2023; where it was noticed the balloon was deflated.The ballon 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 h6: impact code: f2202 captures the reportable event of additional endoscopic procedure.

• 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 S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18290609
• MDR Text Key: 330041389
• Report Number: 3005099803-2023-06590
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AF05105
• Device Lot Number: AF05105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 75 KG