BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPATZ3 ADJUSTABLE BALLOON SYSTEM

    MDR report key: 15819987 · Received November 17, 2022

    Report

    Report Number
    3012638928-2022-02695
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    August 23, 2022
    Report Date
    November 16, 2022
    Manufacturer
    SPATZ FGIA INC.
    Product Code
    LTI
    UDI-DI
    860005178803
    PMA / PMN Number
    P190012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, SPATZ FGIA INC. HAS NOT RECEIVED THE PRODUCT FOR EVALUATION. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: POTENTIAL RISKS ASSOCIATED WITH UPPER ENDOSCOPIC PROCEDURES INCLUDE BUT ARE NOT LIMITED TO: ABDOMINAL CRAMPING AND DISCOMFORT FROM THE AIR USED TO DISTEND THE STOMACH, SORE OR IRRITATED THROAT, BLEEDING, INFECTION, TEARING OF THE ESOPHAGUS OR STOMACH, AND ASPIRATION PNEUMONIA. SOME OF THESE RISKS MAY LEAD TO DEATH. THE RISK INCREASES IF ADDITIONAL PROCEDURES ARE PERFORMED. ACCORDING TO THE AMERICAN COLLEGE OF GASTROENTEROLOGY, RISKS RELATED TO SEDATION DURING ENDOSCOPIC PROCEDURES ARE RARE, OCCURRING IN LESS THAN ONE IN EVERY 10,000 PEOPLE1 . THE MOST COMMON COMPLICATIONS INVOLVE A TEMPORARY DECREASE IN THE RATE OF BREATHING OR HEART RATE, WHICH CAN BE CORRECTED BY GIVING EXTRA OXYGEN OR BY REVERSING THE EFFECT OF THE SEDATIVE MEDICATIONS. DEATH DUE TO ADVERSE EVENTS RELATED TO INTESTINAL OBSTRUCTION, GASTROESOPHAGEAL PERFORATION, AND/OR PULMONARY ASPIRATION IS POSSIBLE ADDITIONAL INFORMATION REGARDING THIS LATE MEDWATCH REPORT- THE FIRM WAS NOT AWARE THAT REPORTS REPORTED TO FDA UNDER CLINICAL SETTING SHOULD ALSO BE REPORTED AS A MEDWATCH REPORT. CAPA WAS ISSUED AND PROCEDURES WERE UPDATED, AND QA DEP. WAS RETRAINED.

    Description of Event or Problem · 0

    (B)(6) 2022: PL UNDERWENT SPATZ PLACEMENT (450 ML) ON 8/18/22. THE CASE WAS UNEVENTFUL. IN EVENING, THE PT REPONED CRAMPING AND LOW BACK PAIN. BY 9 PM THAT NIGHT THE PL WAS ALREADY ASKING FOR BALLOON REMOVAL, FEELING LIKE SHE COULDN'T GET INTO A COMFORTABLE POSITION OR SLEEP, WITH CHEST TIGHTNESS. SHE HAD UNREMARKABLE VITALS AND EXAM THE MORNING AFTER THE PROCEDURE WHEN SHE GOT IV FLUID, PLUS IV TORADOL/ZOFRAN. SHE FELT BETTER BY (B)(6) 2022 BY (B)(6) 2022 SHE FELL WORSE AGAIN AND ASKED 10 HAVE THE BALLOON REMOVED AND WAS NOT INTERESTED IN DOWNWARD ADJUSTMENT BECAUSE OUR SOONEST OPENING WAS 4 DAYS AWAY IN ATLANTA. THE REMOVAL COORDINATED. THE BALLOON REMOVED ON MONDAY (B)(6) 2022. THE PATIENT HAD A COUGH AND THE CRNA DESCRIBED HER AS MORE DIFFICULT TO VENTILATE THAN EXPECTED. ON (B)(6) 2022, DR. SPOKE THE PT. ABOUT NEW SHORTNESS OF BREATH AND CHEST PAIN. SHE WENT 10 HER LOCAL EMERGENCY DEPANMEN1 AND WAS TOLD SHE HAD BILOBAR PNEUMONIA, COVLD NEGATIVE, NO PUHNOOARY CMBOLUS. THE PT WILL BE ADMITTED FOR A FEW DAYS FOR IV ANTIBIOTICS AND NASAL CANNULA SUPPLEMENTAL OXYGEN. PHYSICIAN SUSPECTS ASPIRATION PNEUMONIA, PROBABLY DURING PLACEMENT, BUT THIS IS A BIT OF A DELAY FROM WHAT THEY WOULD EXPECT FROM PLACEMENT AND DYSPNEA. SAE IS PROBABLE IN ATTRIBUTION TO PROCEDURE, POSSIBLE TO DEVICE. PT REPORTS SHE IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768587 SPATZ3 ADJUSTABLE BALLOON SYSTEM GASTRIC BALLOON LTI SPATZ FGIA INC. A-SP3US-03S 211221 860005178803

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Hospitalization| R