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

Model Number B-40800

Device Problems Material Separation (1562); Difficult to Advance (2920)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: patient code f05 is being used to capture the reportable issue of delay to treatment/therapy.

Event Description

It was reported to boston scientific corporation that a bib intragastric balloon system was implanted into the patient on (b)(6) 2023.During the procedure, when the orbera balloon was removed from the semi-rigid casing, it was difficult to pass through the esophagus.There were no patient complications as a result of this event.

Event Description

It was reported to boston scientific corporation that a bib intragastric balloon system was implanted into the patient on (b)(6) 2023.During the procedure, when the orbera balloon was removed from the semi-rigid casing, it was difficult to pass through the esophagus.There were no patient complications as a result of this event.Per additional information received on 29jan2024, the procedure was rescheduled to (b)(6) 2023.

Manufacturer Narrative

Block h6: patient code f05 is being used to capture the reportable issue of delay to treatment/therapy.Block h10: the bib intragastric balloon system was not returned, however based on media analysis, the upper portion of the balloon sheath was detached at the valve.The reported event of balloon sheath material separation was not confirmed.The product was not returned for analysis to identify any defect with the device.Following media analysis, it was determined that the balloon was received with the top portion of the sheath detached at the valve.Most likely procedural factors as lesion characteristics, handling of the device, the technique used by the physician (force applied), could have resulted in the damages encountered in the device, it is possible that the sheath had started to tear prior to opening the packaging and once the package was opened}, the sheath continued to tear and may have made difficult to pass the balloon through the esophagus.Based on all available information, the most probable root cause assigned is adverse event related to procedure.

• 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: 18587037
• MDR Text Key: 333843092
• Report Number: 3005099803-2024-00175
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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-40800
• Device Lot Number: AF05384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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 Sex: Female