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

Lot Number AF05465

Device Problems Deflation Problem (1149); Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problem Vomiting (2144)

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: patient code e1032 is being used to capture the reportable issue of vomiting.Impact code f2202 is being used to capture the reportable issue of endoscopic procedure.

Event Description

It was reported to boston scientific corporation that a bib intragastric balloon system was implanted on (b)(6) 2023 without complications.The patient was taking antiemetics pre-procedure.On november 10, 2023 the patient had green urine and experienced food intolerance.As a result, the patient underwent an additional endoscopic procedure on (b)(6) 2023, which found the balloon was deflated and damaged, and the balloon was explanted.The patient's condition following the procedure was reported to be stable and there were no additional patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a bib intragastric balloon system was implanted on (b)(6) 2023 without complications.The patient was taking antiemetics pre-procedure.On (b)(6) 2023 the patient had green urine and experienced food intolerance.As a result, the patient underwent an additional endoscopic procedure on (b)(6) 2023, which found the balloon was deflated and damaged, and the balloon was explanted.The patient's condition following the procedure was reported to be stable and there were no additional patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: patient code e1032 is being used to capture the reportable issue of vomiting.Impact code f2202 is being used to capture the reportable issue of endoscopic procedure.Block h10: the orbera bib intragastric balloon system was not returned, however based on the investigation provided, the balloon is deflated and it appears to be distorted.The reported event of balloon deflated was confirmed.Media analysis found that the balloon was deflated.Based on the information provided, it was reported that the patient had green urine due to methylene blue.The intragastric balloon system directions for use (ifu) states "the igb is placed in the stomach and filled with sterile saline." for this reason, this event is catalogued as "failure to follow instructions" because the problems traced to the user not following the manufacturer's instructions.For the reported event of balloon damaged/defective, and based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.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.For the reported event of balloon deflated and vomiting, this adverse event 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), for this reason this event is catalogued as "known inherent risk of device." therefore, the most probable root cause for this complaint is cause not established.

• 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: 18402194
• MDR Text Key: 331478634
• Report Number: 3005099803-2023-06814
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: AF05465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 82 KG