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

Model Number A-SP3-03K

Device Problems Deflation Problem (1149); Migration or Expulsion of Device (1395); Obstruction of Flow (2423)

Patient Problem Abdominal Pain (1685)

Event Date 10/30/2023

Event Type  Injury  

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: each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.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.Patients reporting loss of satiety, increased hunger and/or weight gain should be examined radiographically and/or endoscopically, as this is indicative of a balloon deflation.It is necessary to replace a balloon which has spontaneously deflated.Complications- possible complications of the use of the spatz3 adustable balloon system include: balloon deflation and subsequent replacement.

Event Description

Period times of that issue.(b)(6) 2022 - the patient took a weight loss program with a spatz balloon (balloon that goes in the stomach).(b)(6) 2023 - the patient came back to the hospital and explained to the doctor of his symptoms, there is a methylene blue colour in the excretion and urine, which also includes part of a balloon.The doctor completed an egd to find the balloon, but the doctor couldn't find the balloon, the doctor thought the balloon came out with the excretion.(b)(6) 2023 - the patient complained of stomach-ache, the mri centre took a ct scan.The result was a small bowl obstruction at the right lower quadrant.(b)(6) 2023 - doctor knew about the ct report and made an appointment to admit him.(b)(6) 2023 - he went to the hospital again and had an acute stomach-ache.Doctor performed an ng tube and he seemed to get better.(b)(6) 2023 - doctor made an appointment again to operate on him, on (b)(6) 2023.(b)(6) 2023 - operation time at 6 pm.The doctor removed the balloon, at last.From now on the patient is in recovery time at the hospital.

• 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: 18701069
• MDR Text Key: 335296958
• Report Number: 3012638928-2024-03001
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P190012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2024

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 Model Number: A-SP3-03K
• Device Lot Number: 220710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 36 YR
• Patient Sex: Male