BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIB INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 18590538 · Received January 26, 2024

    Report

    Report Number
    3005099803-2024-00170
    Event Type
    Injury
    Date Received
    January 26, 2024
    Date of Event
    October 23, 2023
    Report Date
    August 23, 2024
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6 MEDICAL DEVICE CODE A1406 CAPTURES THE REPORTABLE EVENT OF HYPERINFLATION. MEDICAL DEVICE CODE A120507 CAPTURES THE REPORTABLE EVENT OF BALLOON DIFFICULT TO REMOVE. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL ENDOSCOPIC PROCEDURE. BLOCK A2 PATIENT STARTING WEIGHT:82 KG. PATIENT EVENT WEIGHT: 82 KG. SUMMARY OF INVESTIGATION: A BIB INTRAGASTRIC BALLOON SYSTEM WAS RETURNED TO BOSTON SCIENTIFIC. A VISUAL INSPECTION OF THE BALLOON WAS PERFORMED IT WAS NOTED THAT THERE WAS A LARGE HOLE THAT ROLLED INWARD. ADDITIONALLY, THE BALLOON WAS DISCOLORED DUE MOST LIKELY WITH METHYLENE BLUE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THE IGB IS PLACES IN THE STOMACH AND FILLED WITH STERILE SALINE. THE ALLEGATION OF HYPERINFLATION WAS CONFIRMED, ADDITIONALLY, IN MEDIA ANALYSIS THE PHOTOS PROVIDED BY THE COSTUMER SHOW INFLATION OF THE BALLOON. THE PROBABLE CAUSE HAS BEEN DETERMINED AS KNOW INHERENT RISK OF DEVIE.

    Additional Manufacturer Narrative · 0

    PATIENT STARTING WEIGHT:82 KG. PATIENT EVENT WEIGHT: 82 KG.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA BALLOON WAS IMPLANTED ON (B)(6) 2023, WITH NO COMPLICATIONS. ON (B)(6) 2023, THE PATIENT PRESENTED WITH PAIN. THE PATIENT UNDERWENT AN ENDOSCOPY PROCEDURE ON (B)(6)2023 WHERE IT WAS FOUND THAT THE BALLOON WAS HYPERINFLATED. THE BALLOON WAS EXPLANTED. AFTER PUNCTURING THE BALLOON WITH A NEEDLE, APPROXIMATELY 680ML OF SERUM WAS ASPIRATED WITH METHYLENE BLUE. THE BALLOON WAS SEIZED WITH GRASPER FORCEPS AND REMOVED UNDER CONTINUOUS TRACTION WITH SOME DIFFICULTY. THERE WERE NO REPORTED PATIENT COMPLICATIONS FOLLOWING THE REMOVAL, AND IT WAS REPORTED THAT THE PATIENT IS WELL. NOTE: IT WAS REPORTED THAT METHYLENE BLUE WAS USED WHEN FILLING THE ORBERA BALLOON. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THE IGB IS PLACES IN THE STOMACH AND FILLED WITH STERILE SALINE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORBERA BALLOON WAS IMPLANTED ON (B)(6) 2023 WITH NO COMPLICATIONS. ON (B)(6) 2023 THE PATIENT PRESENTED WITH PAIN. THE PATIENT UNDERWENT AN ENDOSCOPY PROCEDURE ON (B)(6) 2023 WHERE IT WAS FOUND THAT THE BALLOON WAS HYPERINFLATED. THE BALLOON WAS EXPLANTED. AFTER PUNCTURING THE BALLOON WITH A NEEDLE, APPROXIMATELY 680ML OF SERUM WAS ASPIRATED WITH METHYLENE BLUE. THE BALLOON WAS SEIZED WITH GRASPER FORCEPS AND REMOVED UNDER CONTINUOUS TRACTION WITH SOME DIFFICULTY. THERE WERE NO REPORTED PATIENT COMPLICATIONS FOLLOWING THE REMOVAL, AND IT WAS REPORTED THAT THE PATIENT IS WELL. NOTE: IT WAS REPORTED THAT METHYLENE BLUE WAS USED WHEN FILLING THE ORBERA BALLOON. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THE IGB IS PLACES IN THE STOMACH AND FILLED WITH STERILE SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650089 BIB INTRAGASTRIC BALLOON SYSTEM IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI APOLLO ENDOSURGERY B-40800 AF05348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention