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

Device Problem Difficult to Remove (1528)

Patient Problems Airway Obstruction (1699); Respiratory Insufficiency (4462)

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an orbera intragastric balloon system was used on an unknown procedure performed on an unknown date.The account reported difficulty removing the device without the official removal kit (prince medical removal kit) regarding the previous removal treatment for one patient last month, although he could finally remove it, he has failed several times to remove orbera during the treatment even though he tried based on the recommendation on how to use general needle and forceps to remove it.He experienced during surgery that the balloon got stuck in the esophagus and the patient almost suffocated.The physician does not want to do the same removal treatment with general instrument as he believes it compromises patient safety.And he strongly requests to ship official removal kits to japan.Or if a satisfactory solution is not presented to him, he will be exploring a legal option.Apollo had continuously accepted the order of removal kits form japanese doctors at the same timing as orbera before and shipped at the same time of orbera as an official or recommended removal kit.A final decision for the delivery of bsc's official removal kits is required at this time since this physician has another patient scheduled for orbera removal.He must plan the removal treatment for another patient within this month according to the removal period of orbera.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf code e0702 is being used to capture the reportable event of airway obstruction.Imdrf code e0743 is being used to to capture the reportable event of respiratory insufficiency.

• Brand Name: ORBERA 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: 18791177
• MDR Text Key: 336361585
• Report Number: 3005099803-2024-00785
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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