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

Model Number B-50012

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

Patient Problem Insufficient Information (4580)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 impact code f8 is being used to capture the reportable event of hospitalization or prolonged hospitalization.Impact code f2202 is being used to capture the reportable event of endoscopy procedure.Device code a1401 is being used to capture the reportable event of deflation problem.

Event Description

It was reported to boston scientific corporation that an orbera365 intragastric balloon system was implanted on (b)(6) 2022.On december 04, 2023, the patient attended sau due to passing blue urine.The patient was discharged the same day, then on (b)(6) 2023 was re-admitted for persistent symptoms.The balloon was removed on an unknown date.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.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.Additional it was reported that the patient refused the planned removal on (b)(6) 2023.The patient and physician were aware that device was license for 12 months only, however the balloon was explanted on an unknown date after 12 months.The orbera365 intragastric balloon system directions for use (dfu) states "the maximum placement period for the orbera365 system is 12 months, and it must be removed at that time or earlier.

• 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
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19003008
• MDR Text Key: 339250503
• Report Number: 3005099803-2024-01264
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B-50012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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