BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPATZ3 ADJUSTABLE BALLOON SYSTEM

    MDR report key: 22825920 · Received August 18, 2025

    Report

    Report Number
    3012638928-2025-03391
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    June 23, 2025
    Report Date
    September 28, 2025
    Manufacturer
    SPATZ FGIA INC.
    Product Code
    LTI
    PMA / PMN Number
    P190012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THIS REPORT IS BEING SUBMITTED 4 DAYS BEYOND THE REPORTING DEADLINE. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: 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. INJURY TO THE LINING OF THE DIGESTIVE TRACT AS A RESULT OF DIRECT CONTACT WITH THE BALLOON, CATHETER, POLYPECTOMY SNARE, OR AS A RESULT OF INCREASED ACID PRODUCTION BY THE STOMACH - ESOPHAGITIS, GASTRITIS OR DUODENITIS. THIS COULD LEAD TO ULCER FORMATION WITH PAIN, BLEEDING OR EVEN PERFORATION. SURGERY MAY BE NECESSARY TO CORRECT THIS CONDITION AND COULD RESULT IN DEATH. PATIENTS WITH AN INTRAGASTRIC BALLOON WHO EXPERIENCE SEVERE ABDOMINAL PAIN THAT HAVE A NEGATIVE ENDOSCOPY AND X-RAY MAY ADDITIONALLY REQUIRE A CT SCAN TO DEFINITIVELY RULE OUT A PERFORATION. PHYSICIANS HAVE REPORTED THE CONCURRENT USE OF PPI (PROTON PUMP INHIBITOR) AND H2 BLOCKER MEDICATIONS WHICH REDUCE ACID FORMATION OR REDUCE ACIDITY. SILICONE ELASTOMER IS DEGRADED BY ACID. MODERATING THE PH IN THE STOMACH WITH THESE MEDICATIONS SHOULD PROLONG THE INTEGRITY OF THE SPATZ3 ADJUSTABLE BALLOON SYSTEM®, AND THEIR USE IS HIGHLY RECOMMENDED. EACH PATIENT MUST BE MONITORED CLOSELY DURING THE ENTIRE TERM OF TREATMENT IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE COMPLICATIONS.

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS RETURNED FOR ANALYSIS ON AUGUST 20, 2025. THE INSPECTION REVEALED TWO LINEAR CUTS CLOSE TO EACH OTHER ON THE BALLOON SURFACE, MOST LIKELY CAUSED BY A BALLOON GRASPER OR FORCEPS DURING REMOVAL. NO OTHER ISSUES WERE FOUND WITH THE INFLATION SYSTEM OR BALLOON SURFACE. DURING EXAMINATION OF THE RETURNED DEVICE, A TAPE WRAPPED AROUND THE VALVE HOLDER WAS OBSERVED WHICH WAS CONFIRMED THAT THE TAPE WAS APPLIED BY HOSPITAL STAFF AFTER EXTRACTION. IN RELATION TO THE PANCREATITIS REFERENCED IN THE EVENT DESCRIPTION IT WAS CONFIRMED THAT THE PATIENT HAD A PRIOR HISTORY OF PANCREATITIS WHICH HAD BEEN TREATED BEFORE THE IMPLANTATION PROCEDURE. THE IMPLANTATION ENDOSCOPY REPORT DOCUMENTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATIONS. CLINICAL EXPERT ASSESSED THE CASE AND CONCLUDED THAT THE OCCURRENCE OF PANCREATITIS AND THE GASTRIC PERFORATION OCCURRED 10 MONTHS LATER ARE UNRELATED.

    Description of Event or Problem · 0

    THE PATIENT HAS HAD AN INTRAGASTRIC BALLOON IN IMPLANTED WITH 500CC FOR 10 MONTHS, WHICH WAS IMPLANTED IN (B)(6) BY DR. (B)(6). THE INSERTION WAS COMPLICATED BY A COMPRESSIVE ACUTE PANCREATITIS IN (B)(6) 2024. THE PATIENT PRESENTED WITH ABDOMINAL PAIN ASSOCIATED WITH VOMITING FOR 24 HOURS. THERE IS A REPORT OF DARK-COLORED STOOLS AND VOMIT. SHE HAS DIFFUSE ABDOMINAL PAIN WITH GUARDING IN THE LEFT HYPOCHONDRIUM (UPPER LEFT ABDOMINAL REGION). A CT SCAN OF THE ABDOMEN WAS PERFORMED, REVEALING A GASTRIC PERFORATION (MEASURED APPROXIMATELY 1.5 CM IN ITS LARGEST DIMENSION) WITH ASSOCIATED PNEUMOPERITONEUM (AIR IN THE PERITONEAL CAVITY) AND INTRA-PERITONEAL FLUID COLLECTION. THE INTRAGASTRIC BALLOON AND ITS TUBING ARE IN PLACE AND STILL INFLATED. THE DEVICE WAS REMOVED VIA ENDOSCOPE WITHOUT REPLACEMENT AND AN URGENT SURGICAL SUTURING OF THE PERFORATION INTERVENTION WAS VIA LAPAROSCOPIC METHOD.

    Description of Event or Problem · 0

    THE PATIENT HAS HAD AN INTRAGASTRIC BALLOON IN IMPLANTED WITH 500CC FOR 10 MONTHS, WHICH WAS IMPLANTED IN BELGIUM BY DR. (B)(6). THE INSERTION WAS COMPLICATED BY A COMPRESSIVE ACUTE PANCREATITIS IN (B)(6) 2024. THE PATIENT PRESENTED WITH ABDOMINAL PAIN ASSOCIATED WITH VOMITING FOR 24 HOURS. THERE IS A REPORT OF DARK-COLORED STOOLS AND VOMIT. SHE HAS DIFFUSE ABDOMINAL PAIN WITH GUARDING IN THE LEFT HYPOCHONDRIUM (UPPER LEFT ABDOMINAL REGION). A CT SCAN OF THE ABDOMEN WAS PERFORMED, REVEALING A GASTRIC PERFORATION (MEASURED APPROXIMATELY 1.5 CM IN ITS LARGEST DIMENSION) WITH ASSOCIATED PNEUMOPERITONEUM (AIR IN THE PERITONEAL CAVITY) AND INTRA-PERITONEAL FLUID COLLECTION. THE INTRAGASTRIC BALLOON AND ITS TUBING ARE IN PLACE AND STILL INFLATED. THE DEVICE WAS REMOVED VIA ENDOSCOPE WITHOUT REPLACEMENT AND AN URGENT SURGICAL SUTURING OF THE PERFORATION INTERVENTION WAS VIA LAPAROSCOPIC METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590405 SPATZ3 ADJUSTABLE BALLOON SYSTEM GASTRIC BALLOON LTI SPATZ FGIA INC. A-SP3-03K 231210

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Life Threatening| H| R