BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPATZ3 ADJUSTABLE BALLOON SYSTEM

    MDR report key: 23002098 · Received September 9, 2025

    Report

    Report Number
    3012638928-2025-03417
    Event Type
    Injury
    Date Received
    September 9, 2025
    Report Date
    September 9, 2025
    Manufacturer
    SPATZ FGIA INC.
    Product Code
    LTI
    PMA / PMN Number
    P190012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, SPATZ FGIA INC. HAS NOT RECEIVED THE PRODUCT FOR EVALUATION, THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: EACH PATIENT MUST BE MONITORED CLOSELY DURING THE ENTIRE TERM OF TREATMENT IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE COMPLICATIONS. EACH PATIENT SHOULD BE INSTRUCTED TO REPORT TO PHYSICIANS IMMEDIATELY REGARDING ANY AND ALL CHANGE OF SYMPTOMS. SYMPTOMS OF DEFLATION, GASTROINTESTINAL OBSTRUCTION, ULCERATION AND OTHER COMPLICATIONS WHICH MIGHT OCCUR SHOULD BE REVIEWED WITH PATIENT, AND PATIENTS SHOULD BE ADVISED TO CONTACT HIS/HER PHYSICIAN IMMEDIATELY UPON THE ONSET OF SUCH SYMPTOMS. PATIENTS REPORTING LOSS OF SATIETY, INCREASED HUNGER AND/OR WEIGHT GAIN SHOULD BE EXAMINED RADIOGRAPHICALLY AND/OR ENDOSCOPICALLY, AS THIS IS INDICATIVE OF A BALLOON DEFLATION. IT IS NECESSARY TO REPLACE A BALLOON WHICH HAS SPONTANEOUSLY DEFLATED. COMPLICATIONS- POSSIBLE COMPLICATIONS OF THE USE OF THE SPATZ3 ADUSTABLE BALLOON SYSTEM INCLUDE: BALLOON DEFLATION AND SUBSEQUENT REPLACEMENT.

    Description of Event or Problem · 0

    A 23-YEAR-OLD FEMALE HAD A HISTORY OF A GASTRIC BALLOON PROCEDURE PERFORMED ONE YEAR AGO IN A PRIVATE HOSPITAL, BUT THERE WAS NO FOLLOW-UP. SHE PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF GENERALIZED ABDOMINAL PAIN, RECURRENT VOMITING, AND CONSTIPATION, BUT SHE WAS ABLE TO PASS FLATUS. THE ABDOMINAL PAIN WAS NON-RADIATING, AND THE VOMITING HAD RENDERED HER UNABLE TO EAT. SHE DID NOT REPORT LOOSE MOTIONS, FEVER, OR URINARY SYMPTOMS. ON PHYSICAL EXAMINATION, SHE HAD ABDOMINAL DISTENSION, A SOFT, LAX ABDOMEN WITH MILD TENDERNESS, AND MILDLY EXAGGERATED BOWEL SOUNDS, BUT OTHERWISE SHE WAS VITALLY STABLE. AFTER SHE ARRIVED IN THE EMERGENCY ROOM, PLAN X-RAY ABDOMEN SHOWED DILATED JEJUNAL LOOPS AND AN ULTRASOUND (US) OF HER ABDOMEN WAS CARRIED OUT, AND IT WAS DISCOVERED THAT THE GASTRIC BALLOON IN THE LEFT UPPER QUADRANT OF THE STOMACH LUMEN HAD DRASTICALLY SHRUNK, INDICATING THAT IT MAY HAVE RUPTURED. NEVERTHELESS, THE BALLOON WAS NOT VISIBLE DURING THE UPPER ENDOSCOPY THAT SHE HAD LATER. FOLLOWING THE INITIAL EVALUATIONS, THE PATIENT HAD AN URGENT COMPUTED TOMOGRAPHY (CT) ABDOMINAL SCAN, WHICH REVEALED THAT THE MIGRATING COLLAPSED GASTRIC BALLOON, WHICH WAS TRAPPED IN THE SMALL BOWEL LOOPS WITH PROXIMALLY DILATED LOOPS, WAS THE CAUSE OF THE SMALL INTESTINAL OBSTRUCTION (SBO). THE MIGRATING IGB WAS DETERMINED TO BE THE SOURCE OF THE PATIENT'S SMALL INTESTINAL BLOCKAGE. AS THE PATIENT WAS HEMODYNAMICALLY STABLE AND THE GOAL WAS FOR THE BALLOON TO TRANSIT NATURALLY DOWN THE ALIMENTARY TRACT, THE SURGICAL TEAM ADVISED CONSERVATIVE CARE AT THIS POINT. DESPITE CONSERVATIVE EFFORTS, THE PATIENT DID NOT SHOW ANY IMPROVEMENT AFTER FIVE DAYS FROM ADMISSION, SO SURGICAL INTERVENTION BECAME NECESSARY. THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION, WHERE WE IDENTIFIED THE AREA OF SMALL BOWEL OBSTRUCTION (SBO), AND WE APPRECIATED THE BALLOON IN IT. A MINI LAPAROTOMY THROUGH WIDENING OF THE UMBILICAL PORT TO AVOID SOILING AFTER THE ENTEROTOMY TO EXTRACT THE MIGRATED INTRAGASTRIC BALLOON. THE BALLOON WAS FOUND IN THE JEJUNAL LOOP, CAUSING DILATATION OF THE SMALL BOWEL PROXIMAL TO THE OBSTRUCTION AND COLLAPSE DISTALLY. THERE WAS FREE FLUID IN THE PELVIS AND HYPEREMIA WAS OBSERVED AT THE BALLOON LOCATION. FOLLOWING PROXIMALLY MILKING THE GASTRIC BALLOON AWAY FROM THE OBSTRUCTION AND HYPEREMIC BOWEL, A LONGITUDINAL INCISION WAS MADE FOR THE ENTEROTOMY, THE BALLOON WAS REMOVED, AND THE ENTEROTOMY SITE WAS CLOSED TRANSVERSELY TO PREVENT BOWEL STRICTURE. THE REPAIRED BOWEL WAS RETURNED BACK TO THE ABDOMEN AND ABDOMINAL WOUND WAS CLOSED IN LAYERS. SINCE THE FIELD WAS PRISTINE AND THERE HAD NOT BEEN SIGNIFICANT BOWEL CONTENT SOILING, WE CHOSE NOT TO INSTALL A DRAIN IN THIS CASE. ON THE FIFTH POSTOPERATIVE DAY, THE PATIENT'S CONDITION STABILIZED, AND SHE WAS ALLOWED TO GO HOME WITH REGULAR BOWEL MOVEMENTS AND GOOD DIET TOLERANCE. AFTER A FOLLOW-UP EVALUATION AT THE CLINIC AFTER A FORTNIGHT, THE PATIENT WAS ALLOWED TO RETURN TO HER USUAL ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465828 SPATZ3 ADJUSTABLE BALLOON SYSTEM GASTRIC BALLOON LTI SPATZ FGIA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Life Threatening| H| R