BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPATZ3 ADJUSTABLE BALLOON SYSTEM

    MDR report key: 20154410 · Received September 6, 2024

    Report

    Report Number
    3012638928-2024-03153
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 6, 2024
    Manufacturer
    SPATZ FGIA INC.
    Product Code
    LTI
    PMA / PMN Number
    P190012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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

    BALLOON PRESENTED HYPERINFLATION. IT PRESSED ON THE PATIENT'S STOMACH, CAUSING A PERFORATION IN THE ORGAN. THE BALLOON WAS REMOVED, AND A SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042423 SPATZ3 ADJUSTABLE BALLOON SYSTEM GASTRIC BALLOON LTI SPATZ FGIA INC. A-SP3-03K

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Life Threatening| R| H