BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA¿ INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 14642995 · Received June 9, 2022

    Report

    Report Number
    3006722112-2022-00048
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 12, 2022
    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

    INITIAL MEDWATCH SUBMITTED TO THE FDA ON 09/MAY/2022. 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 TIP DIFFICULTY ADDING/REMOVING SALINE" 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. ADDITIONAL INFORMATION: COMPETITOR DEVICE USED FOR COMPLAETE THE CASE. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE INVESTIGATOR IS WAITING UNTIL THE LOT NUMBER OF THE DEVICE IS KNOWN TO DETERMINE WHETHER A DEVICE HISTORY RECORD (DHR) REVIEW IS OR IS NOT REQUIRED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    WHILE FILLING THE BALLOON A LEAK WAS NOTICED AND HAD TO USE A COMPETITORS DEVICE TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678931 ORBERA¿ INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON SYSTEM LTI APOLLO ENDOSURGERY, INC. B-50012 AF04914 10811955020725

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male