MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA365 INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number B-50012

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure with a patient under anesthesia.

Event Description

It was reported to boston scientific corporation that an orbera365 intragastric balloon was going to be implanted on (b)(6) 2024.During preparation, outside the patient, the balloon had a dislocated cylindrical silicone end and at the first manipulation the balloon was leaking.The procedure was not completed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block e2: health professional was approximated to yes as the event was reported to have occurred at a health care facility.Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure with a patient under anesthesia.Block h10: investigation summary: with all the available information boston scientific concludes that the as reported code of balloon sheath material separation can be confirmed; however, the reported code of fluid leak could not be verified as the device did not leak during functional testing.Device history review.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device product analysis.Balloon was received with the bottom portion of the sheath detached.The remaining sheath is attached on the top portion of the balloon at the valve.The fill tip is connected into the valve.There is remanence of sodium bicarbonate present on the shell.Under microscopic analysis, the sheath appears to have been ripped off.A leak test was performed and there were no leaks observed on the shell or from the valve.Labeling review.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Risk review.A risk review of the orbera was completed and confirmed that the event of sheath material separation and fluid leak were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion.Based on the information provided, the balloon was received with the bottom portion of the sheath detached.The most probable cause selected for this investigation will be manufacturing deficiency since the problem is traced to manufacturing process.During functional testing, there was no leak observed; therefore, the as reported code of fluid leak could not be verified.

Event Description

It was reported to boston scientific corporation that an orbera365 intragastric balloon was going to be implanted on (b)(6) 2024.During preparation, outside the patient, the balloon had a dislocated cylindrical silicone end and at the first manipulation the balloon was leaking.The procedure was not completed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: ORBERA365 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: 18803643
• MDR Text Key: 336512246
• Report Number: 3005099803-2024-00804
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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-50012
• Device Lot Number: AF05689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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