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 Abdominal Pain (1685); Dehydration (1807); Nausea (1970); Vomiting (2144)

Event Date 05/30/2023

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

A patient with hyperinflation, removal of the balloon was scheduled.She had the balloon for 4-5 months.The balloon was implanted on (b)(6) 2023, weight at implantation 187ib, the volume of the balloon was 550 ml.Implantation procedure without any complications.Date of the event on (b)(6) 2023 unscheduled endoscopic visit, weight at removal 136ib, patient reported severe nausea and vomiting moderate abdominal discomfort and pain, concentrated urine, or signs of dehydration.

• 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: 17246105
• MDR Text Key: 318567846
• Report Number: 3012638928-2023-02846
• 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: 07/03/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2023
• Initial Date FDA Received: 07/03/2023
• 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 Sex: Female
• Patient Weight: 62 KG