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

Model Number A-SP3US-03K

Device Problems Patient-Device Incompatibility (2682); Air/Gas in Device (4062)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

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 can occur in fluid-filled intragastric balloons.It is characterized by the spontaneous hyperinflation of the balloon with air causing an enlargement of the balloon, which can lead to abdominal pain, nausea and vomiting, and in severe cases it can lead to ulceration, and rarely it can cause gastric perforation and death.Any change in symptoms - new onset nausea, vomiting, pain, or trouble breathing - needs to be addressed by the physician to rule out, among other things, spontaneous hyperinflation.If a balloon is found to be hyperinflated, it should be removed.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.Spontaneous hyperinflation occurs due to gas production within the balloon.Spontaneous hyperinflation can cause abdominal pain, nausea and vomiting, and in severe cases it can lead to ulceration, and rarely it can cause gastric perforation and death.

Event Description

The patient underwent placement to 550 ml on (b)(6) 2023.The patient had about 2 months of manageable upper gi symptoms of nausea and bloating.She had ppi-responsive gerd following placement.Between her (b)(6) 2023 visit, she had resumed omeprazole (which she had forgotten to take), and this was associated with liquid stools without upper gi symptoms.The doctor determined to switch to pantoprazole to see if this was agent specific ppi-associated diarrhea.Loose stools were minimal at time of adjustment (b)(6) 2023, and she otherwise was feeling well and eager to pursue up adjustment for a 2-month weight loss stall and increase in hunger.The doctor increased it by 200 ml (for ppi-responsive gerd).At follow up, (b)(6) 2023, liquid stools had re-emerged intensified, and she has nausea and bloating much like after initial spatz placement.We decided to treat empirically for a sibo-like syndrome on (b)(6) 2023 with per-protocol metronidazole.On monday (b)(6) she presented to our center for iv hydration for lightheadedness and nausea/vomiting, and she was additionally found to have abdominal distention but not pain/blue urine, without obstipation/constipation.We planned for downsizing on (b)(6) but this is when we encountered hyperinflation and therefore opted for complete balloon removal.The doctor re-prescribed the metronidazole following explanation.The patient is doing well now, the doctor scheduled a formal follow up.

• Brand Name: SPATZ3 ADJUSTABLE BALLOON SYSTEM
• Type of Device: GASTRIC BALLOON
• Manufacturer (Section D): SPATZ FGIA INC.; 1801 s perimeter rd ste 130; fort lauderdale FL 33309
• Manufacturer (Section G): SPATZ FGIA INC.; 1801 s perimeter rd ste 130; fort lauderdale FL 33309
• Manufacturer Contact: pnina polishuk ; 1801 s perimeter rd ste 130; fort lauderdale, FL 33309
• MDR Report Key: 17133606
• MDR Text Key: 318085422
• Report Number: 3012638928-2023-02838
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 860005178803
• UDI-Public: (01)860005178803(11)2021-12-21(17)2023-12-21(10)211221
• 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
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/15/2023
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Race: Black Or African American