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

Model Number B-40800

Device Problem Material Integrity Problem (2978)

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

Event Date 12/17/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation that an implantation procedure for a bib intragastric balloon system was scheduled for (b)(6) 2024.Upon opening the bib box, while the patient was sedated for the procedure, the physician found irregularities at the tip junction and the balloon connection.The procedure was postponed and rescheduled for (b)(6) 2023.There were no patient complications as a result of this event.

Manufacturer Narrative

Impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.Investigation summary with all the available information boston scientific concludes that the as reported code of "balloon damaged/defective" can be confirmed since the balloon was received with the top portion of the sheath detached at the valve.Device/media analysis the balloon was received with the top portion of the sheath detached at the valve.Under microscopic analysis, the sheath appears to be torn as it has jagged edges.Risk review a risk review of the orbera was completed and confirmed that the events of "balloon damaged/defective" and "delay to treatment/ therapy" were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Device history 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.Investigation conclusion based on all gathered information, boston scientific concludes that the reported event of "balloon damaged/defective" can be confirmed.The most probable cause assigned to this investigation is adverse event related to procedure.This conclusion was selected because during the product analysis, the balloon was returned 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.The conclusion is acceptable because the adverse event occurred during the procedure and the device had no influence on event.All compiled information on this investigation determines that the most probable cause is "adverse event related to procedure.".

Event Description

It was reported to boston scientific corporation that an implantation procedure for a bib intragastric balloon system was scheduled for (b)(6) 2024.Upon opening the bib box, while the patient was sedated for the procedure, the physician found irregularities at the tip junction and the balloon connection.The procedure was postponed and rescheduled for (b)(6) 2023.There were no patient complications as a result of this event.

• 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: 18520024
• MDR Text Key: 333239913
• Report Number: 3005099803-2023-07169
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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