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

Model Number B-40800

Device Problem Material Separation (1562)

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

Event Date 01/27/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a bib intragastric balloon system was used on an intragastric balloon placement procedure used to treat obesity performed on (b)(6) 2024.During insertion of the balloon, the balloon could not be implanted because the sheath was partially open and did not allow safe passage through the esophagus.Due to this, the procedure was not able to be completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf code f1001 is capturing the reportable event of aborted procedure.

• Brand Name: BIB INTRAGASTRIC BALLOON SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY; 4221 freidrich ln.; ste 195; 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: 18710772
• MDR Text Key: 335466297
• Report Number: 3005099803-2024-00507
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Other
• Type of Report: Initial
• Report Date: 02/15/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: B-40800
• Device Lot Number: AF05225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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): Other