BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA INTRAGASTRIC BALLOON

    MDR report key: 17350818 · Received July 19, 2023

    Report

    Report Number
    3006722112-2023-00140
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 23, 2023
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020619
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINED MEDWATCH SUBMITTED TO THE FDA ON 19/JUL/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: THE INVESTIGATOR DETERMINED THAT A DEVICE HISTORY RECORD (DHR) REVIEW IS REQUIRED FOR THIS COMPLAINT DUE TO THE COMPLAINT BEING MDR REPORTABLE. THE SUBJECT PRODUCT MET ALL SPECIFICATIONS AND REQUIREMENTS IN EFFECT AT THE TIME OF MANUFACTURE. THERE ARE NO OTHER COMPLAINTS AGAINST THIS LOT NUMBER, AF05291, AND ALLEGATION. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE APOLLO DEVICE ANALYSIS LABORATORY ON 07/JULY/2023. A NON-INFLATED BALLOON WAS RETURNED WITH THE FILL TUBE TIP DISCONNECTED FROM THE SLIT VALVE. THE FILL TIP WAS REINSERTED INTO THE SLIT VALVE AND THE END OF THE BALLOON WAS CLAMPED ONTO THE PULL FORCE EQUIPMENT, AND IT MET MINIMUM REQUIREMENTS. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE BALLOON DID NOT INFLATE, AND THE FILL TIP DISCONNECTED FROM THE SLIT VALVE. THE FILL TIP WAS MEASURED USING A PIN GAUGE AND IT MET SPECIFICATIONS. THE COMPLAINT HAS BEEN VERIFIED AS THE PRESSURE TO INFLATE THE BALLOON EXCEEDED REQUIREMENTS. : LAB ANALYSIS WAS ABLE TO REPLICATE THE REPORTED EVENT OF "DIFFICULTY WITH FILL TUBE", AS THE FILL PRESSURE EXCEEDED MINIMUM REQUIREMENTS. THE USER EFFECTS OF "DIFFICULTY WITH FILL TUBE" IS KNOWN AND LABELED POSSIBLE ADVERSE EVENT.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THE BALLOON SEPARATED FROM THE CATHETER WHEN PASSING THROUGH THE ESOPHAGUS. CASE WAS ABORTED AND COMPLETED THE FOLLOWING DAY. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905906 ORBERA INTRAGASTRIC BALLOON INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-4800 AF05291 10811955020619

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male