MAUDE Adverse Event Report: SPATZ FGIA INC. SPATZ3 ADJUSTABLE BALLOON SYSTEM; GASTRIC BALLOON

Model Number A-SP3US-03K

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

Upon receipt of this event spatz had investigated the case and found that the patient had active acid reflux requiring ppi for control - symptoms recurred with missed dosing.Under those circumstances the post approval study protocol states that 200 ml is the recommended balloon adjustment however, the patient was given an addition of 300 ml.Additionally, a review of the device labeling notes the following: failure of patients to take prescribed daily proton-pump inhibitor medication increases the risk of gastric ulceration or perforation.Each patient must be monitored closely during the entire term of treatment to detect the development of possible complications.Each patient should be instructed regarding signs and symptoms of balloon deflation, gastrointestinal obstruction, perforation, ulceration, and other complications, which might occur, and should be advised to contact his/her physician immediately upon the onset of such signs and symptoms.Any change in symptoms - new onset nausea, vomiting, pain, or trouble breathing - needs to be addressed by the doctor.The cause may include dietary indiscretion, ulceration, hyperinflation, perforation, or obstruction.In certain circumstances the doctor will choose to do an x-ray, or endoscopy, if dietary/medication changes do not alleviate symptoms.Prompt attention is recommended to prevent serious complications.Inflation volumes above 850 ml are not recommended and may increase risk of intolerance, balloon deflation, gastric ulceration and/or gastric perforation.Section 10.3.D - balloon volume up-adjustments are recommended for patients between weeks 14-24, who have diminished balloon effect, and who are asymptomatic, with bmi above 25, and without any evidence of gastric ulcer, erosive gastritis, esophagitis (any grade).A letter was sent to all study pis emphasizing the criteria for up adjustment and the importance of following the post approval study protocol.

Event Description

On (b)(6) 2022, a spatz3 balloon was implanted in subject (b)(6).On (b)(6) 2022, the patient who was enrolled in the post approval study received a scheduled week 18 up-adjustment - 300ml of volume was added.The patient presented to the hospital with abdominal pain which began on the evening of on (b)(6) 2022.The patient states the pain came on suddenly while she was at rest.Pain is described as sharp, severe, and located in the left upper quadrant.The pain radiated throughout the abdomen.Nothing seemed to make the pain better or worse.The pain progressively worsened, and was associated with nausea and vomiting.No other associated symptoms.Work-up in the emergency department revealed free air on abdominal x-ray and a perforation along the anterior aspect of the gastric body was repaired with laparoscopic surgery on (b)(6) 2022.The balloon was operatively removed by the hospital surgeon.Study staff are awaiting surgical records and follow-up reports.The patient fully recovered and is in good health.

• Brand Name: SPATZ3 ADJUSTABLE BALLOON SYSTEM
• Type of Device: GASTRIC BALLOON
• Manufacturer (Section D): SPATZ FGIA INC.; 1801 s perimeter rd, suite 130; fort lauderdale; florida FL 33309
• Manufacturer (Section G): SPATZ FGIA INC.; 1801 s perimeter rd, suite 130; fort lauderdale; florida FL 33309
• MDR Report Key: 16071841
• MDR Text Key: 306370814
• Report Number: 3012638928-2022-02751
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2023
• Device Model Number: A-SP3US-03K
• Device Lot Number: 211221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American