BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA 365 INTRAGASTRIC BALLOON

    MDR report key: 17549700 · Received August 15, 2023

    Report

    Report Number
    3006722122-2023-00159
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 14, 2023
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020725
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINED MEDWATCH SUBMITTED TO THE FDA ON 15/AUG/2023. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT ORBERA¿ INTRAGASTRIC BALLOON SYSTEM DIRECTIONS FOR USE (DFU) ADDRESSES THE KNOWN AND ANTICIPATED POTENTIAL EVENTS OF DIFFICULTY WITH FILL TUBE ARE AS FOLLOWS: WARNINGS AND PRECAUTIONS: PROPER POSITIONING OF THE PLACEMENT CATHETER ASSEMBLY AND THE BIB¿ SYSTEM BALLOON WITHIN THE STOMACH IS NECESSARY TO ALLOW PROPER INFLATION. LODGING OF THE BALLOON IN THE ESOPHAGEAL OPENING DURING INFLATION MAY CAUSE INJURY AND/OR DEVICE RUPTURE. THE ORBERA¿ INTRAGASTRIC BALLOON SYSTEM IS COMPOSED OF SOFT SILICONE ELASTOMER AND IS EASILY DAMAGED BY INSTRUMENTS OR SHARP OBJECTS. THE BALLOON MUST BE HANDLED ONLY WITH GLOVED HANDS AND WITH THE INSTRUMENTS RECOMMENDED IN THIS DOCUMENT. NOTE: IF THE BALLOON BECOMES SEPARATED FROM THE SHEATH PRIOR TO PLACEMENT, DO NOT ATTEMPT TO USE THE BALLOON OR REINSERT THE BALLOON INTO THE SHEATH. NOTE: DURING THE FILLING PROCESS THE FILL TUBE MUST REMAIN SLACK. IF THE FILL TUBE IS UNDER TENSION DURING THE INTUBATION PROCESS, THE FILL TUBE MAY DISLODGE FROM THE BALLOON, PREVENTING FURTHER BALLOON DEPLOYMENT. WARNING: PATIENTS MUST BE ADVISED THAT THE IGB IS INTENDED TO BE PLACED FOR 6 MONTHS MAXIMALLY, AT WHICH POINT REMOVAL IS REQUIRED. LONGER PERIODS OF IGB PLACEMENT INCREASE THE RISK OF IGB DEFLATION (A REDUCTION IN SIZE OF THE DEVICE DUE TO LOSS OF SALINE) WHICH CAN LEAD TO INTESTINAL OBSTRUCTION AND RISK FOR DEATH. THE RISK OF THESE EVENTS IS ALSO SIGNIFICANTLY HIGHER WHEN IGBS ARE FILLED TO A LARGER VOLUME THAN INDICATED (GREATER THAN 700CC). WARNING: WHEN FILLING THE IGB DURING THE PLACEMENT PROCEDURE, AVOID RAPID FILL RATES AS THESE WILL GENERATE HIGH PRESSURE WHICH CAN DAMAGE THE IGB VALVE OR CAUSE PREMATURE DETACHMENT OF THE IGB FROM THE TIP OF THE PLACEMENT CATHETER. THE LABELING IS ADEQUATE AS IT ADDRESSES THE REPORTED COMPLAINT. ADDITIONAL INFORMATION: A DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUIRED DUE TO THE COMPLAINT BEING MDR REPORTABLE. THE SUBJECT PRODUCT MET ALL SPECIFICATIONS AND REQUIREMENTS IN EFFECT AT THE TIME OF MANUFACTURE. THERE WERE NO OTHER COMPLAINTS IN THE APOLLO DATABASE AGAINST THIS LOT NUMBER. AF05524 AND ALLEGATION. DEVICE EVALUATION SUMMARY: (IF FINAL REPORT WITH COMPLETED INVESTIGATION) THE DEVICE WAS RETURNED TO THE APOLLO DEVICE ANALYSIS LABORATORY ON 08/AUG/2023. A NON-INFLATED BALLOON WITH THE FILL TIP DISCONNECTED FROM THE VALVE WAS RETURNED. THE SHEATH IS PRESENT ON THE SHELL. THE FILL TIP WAS RECONNECTED INTO THE VALVE AND THE END OF THE BALLOON WAS CLAMPED ONTO THE PULL FORCE EQUIPMENT AND IT MET THE MINIMUM REQUIREMENTS. THE FILL TIP PRESSURE TO INFLATE THE BALLOON MET THE MINIMUM REQUIREMENTS. ONCE INFLATED, AN AIR LEAK TEST WAS PERFORMED ON THE DEVICE, AND THE SHEATH BROKE AWAY AS INTENDED AND THERE WERE NO LEAKS. THE BALLOON WAS THEN SUBMERGED IN WATER AND THERE WERE NO LEAKS FROM THE VALVE. A PIN GAUGE WAS USED TO CHECK THE CIRCUMFERENCE OF THE FILL TUBE TIP AND IT MET SPECIFICATIONS. THE COMPLAINT COULD NOT BE VERIFIED AS THE DEVICE PERFORMED AS INTENDED ONCE THE FILL TIP WAS RECONNECTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED VALVE WAS IN A BAD STATE AND THE BALLOON COULD NOT BE FILLED. PROCEDURE NOT COMPLETED WITH BACKUP DEVICE AND WAS RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793836 ORBERA 365 INTRAGASTRIC BALLOON INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 AF05524 10811955020725

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male