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

Model Number B-40800

Device Problem Inflation Problem (1310)

Patient Problem Discomfort (2330)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Medical device code a1406 captures the reportable event of hyperinflation.Imdrf impact code f2202 captures the reportable event of additional endoscopic procedure.

Event Description

It was reported to boston scientific corporation that a bib intragastric balloon was implanted (b)(6) 2023.Three months later (date unknown), the patient presented with discomfort.The physician confirmed through x-ray that the balloon was hyperinflated.The patient underwent an endoscopy procedure on (b)(6) 2024 to remove the balloon.There were no reported patient complications following the removal, and it was reported that the patient is well.

Event Description

It was reported to boston scientific corporation that a bib intragastric balloon was implanted (b)(6) 2023.Three months later (date unknown), the patient presented with discomfort.The physician confirmed through x-ray that the balloon was hyperinflated.The patient underwent an endoscopy procedure on (b)(6) 2024 to remove the balloon.There were no reported patient complications following the removal, and it was reported that the patient is well.

Manufacturer Narrative

Correction: block h6: imdrf code f2203: imaging required captures the event of x-ray.Additional information: investigation summary: device media analysis: based on the photos provided, it does show that the balloon is hyperinflated.Instructions for use (ifu)/label review.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.The ifu contains detailed device information and instructions for the device use.Additionally, it was confirmed that the following adverse events are anticipated in the ifu: balloon spontaneous inflation and discomfort.Also, there is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Risk review a risk review was completed and confirmed that the event of "balloon spontaneous inflation, discomfort and endoscopic procedure" were defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Device history record (dhr) review it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event (refer to attached dhr review).Investigation conclusion for the as reported balloon spontaneous inflation and discomfort these adverse events are 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 these events are catalogued as "known inherent risk of device.".

• 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: 19007214
• MDR Text Key: 338978687
• Report Number: 3005099803-2024-01359
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 05/09/2024

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-40800
• Device Lot Number: AF05391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2023
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male