BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPATZ3 ADJUSTABLE BALLOON SYSTEM

    MDR report key: 21906792 · Received April 25, 2025

    Report

    Report Number
    3012638928-2025-03321
    Event Type
    Injury
    Date Received
    April 25, 2025
    Report Date
    April 25, 2025
    Manufacturer
    SPATZ FGIA INC.
    Product Code
    LTI
    PMA / PMN Number
    P190012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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: SPONTANEOUS HYPERINFLATION IS THE ENLARGEMENT OF THE BALLOON WITH EXTRA AIR THAT CAN OCCUR SPONTANEOUSLY. THIS CAN LEAD TO SYMPTOMS SUCH AS PAIN, NAUSEA, VOMITING, DEHYDRATION, ULCERATION, PERFORATION, AND COULD REQUIRE A DOWN ADJUSTMENT OR REMOVAL OF THE BALLOON. 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.

    Description of Event or Problem · 0

    A 47-YEAR-OLD WOMAN PRESENTED WITH A SUDDEN-ONSET, SEVERE, GENERALIZED, NON-RADIATING ABDOMINAL PAIN. SHE HAD UNDERGONE THE PLACEMENT OF AN ADJUSTABLE IGB (SPATZ3) FOUR MONTHS EARLIER, WITH AN INITIAL INFLATION VOLUME OF 500 ML OF STERILE WATER. HER BODY MASS INDEX (BMI) HAD DECREASED FROM 35.9 KG/M² AT THE TIME OF INSERTION TO 29.8 KG/M² OVER FOUR MONTHS. UPON ARRIVAL AT THE EMERGENCY DEPARTMENT, SHE WAS AFEBRILE BUT DEHYDRATED, TACHYCARDIC, AND NORMOTENSIVE. AN ABDOMINAL EXAMINATION REVEALED EPIGASTRIC FULLNESS, TENDERNESS, AND LOCALIZED GUARDING. A PLAIN ABDOMINAL X-RAY DEMONSTRATED A GROSSLY OVERDISTENDED IGB OCCUPYING ALMOST HALF OF THE ABDOMINAL CAVITY. HOWEVER, THE X-RAY DID NOT INCLUDE THE DOMES OF THE DIAPHRAGM, WHICH LIMITED ITS ABILITY TO DETECT PNEUMOPERITONEUM. A CHEST X-RAY IN AN ERECT POSITION WAS NOT PERFORMED, AS THE DECISION WAS MADE TO PROCEED WITH A CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CECT) SCAN FOR A MORE THOROUGH ASSESSMENT FOLLOWING THE IDENTIFICATION OF THE HYPERINFLATED BALLOON. THE CT SCAN CONFIRMED THE PRESENCE OF PNEUMOPERITONEUM, GASTRIC WALL THICKENING WITH AIR POCKETS, FAT STRANDING, AND FREE INTRAPERITONEAL FLUID, SUGGESTIVE OF PERFORATED VISCUS. WHILE AN ERECT CHEST X-RAY MAY HAVE HELPED DETECT FREE AIR UNDER THE DIAPHRAGM, CT IMAGING WAS PRIORITIZED DUE TO ITS SUPERIOR SENSITIVITY IN EVALUATING THE EXTENT OF THE PERFORATION AND ASSOCIATED INTRA-ABDOMINAL PATHOLOGY, WHICH WAS CRUCIAL FOR SURGICAL PLANNING. THE PATIENT WAS PROMPTLY TAKEN TO THE OPERATING THEATER, WHERE ON-TABLE ESOPHAGOGASTRODUODENOSCOPY (OGDS) CONFIRMED THE PRESENCE OF A HYPERINFLATED IGB. THE BALLOON WAS DEFLATED VIA ASPIRATION OF 500 ML OF FLUID ALONG WITH GAS BUBBLES AND WAS REMOVED ENDOSCOPICALLY. LAPAROSCOPIC EXPLORATION REVEALED A 1 CM PRE-PYLORIC GASTRIC PERFORATION WITH GROSS PURULENT CONTAMINATION EXTENDING TO ALL QUADRANTS OF THE ABDOMEN. A LAPAROSCOPIC PRIMARY REPAIR OF THE GASTRIC ULCER WAS PERFORMED AND REINFORCED WITH A PEDICLED GREATER OMENTUM. THE ASPIRATED IGB FLUID WAS SENT FOR CULTURE AND SENSITIVITY, BUT NO BACTERIAL OR FUNGAL GROWTH WAS IDENTIFIED. POSTOPERATIVELY, THE PATIENT WAS CLOSELY MONITORED AND GRADUALLY REINTRODUCED TO ORAL FEEDING. SHE SHOWED AN UNEVENTFUL RECOVERY AND UNDERWENT HELICOBACTER PYLORI ERADICATION THERAPY. A REPEAT OGDS PERFORMED A MONTH LATER SHOWED A WELL-HEALED GASTRIC ULCER WITH NO EVIDENCE OF MALIGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276610 SPATZ3 ADJUSTABLE BALLOON SYSTEM GASTRIC BALLOON LTI SPATZ FGIA INC. A-SP3-03K

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Hospitalization| R