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

Model Number A-SP3-03K

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Low Oxygen Saturation (2477); Bronchospasm (2598)

Event Date 03/21/2024

Event Type  Death  

Manufacturer Narrative

The company has requested the autopsy report to determine the cause of death and its relation to the device/procedure and we will provide a follow up report when new information will be revealed.

Event Description

Healthcare provider's report: on (b)(6) 2023, spatz3 balloon was implanted without any complications.The procedure proceeded normally, without any complications, although the patient experienced symptoms such as abdominal pain, nausea, and vomiting in the four following days, which later subsided.In january, the patient contacted the clinic reporting that she was no longer losing weight and expressed a desire to adjust the balloon because she claimed to be eating normally but not losing weight.She was offered the option to adjust the balloon by an additional 100ml, and the procedure was scheduled for (b)(6) 2024.On (b)(6) 2024, the patient attended the clinic for the adjustment of the balloon.When asked about preparation, she claimed to have followed it correctly.However, during the procedure, upon inserting the probe, it was found that the preparation had not been done properly due to the presence of food, which prevented the continuation of the examination due to the risk of broncho aspiration.The patient reported consuming kibbeh during the four days of preparation.The patient was explained the importance of proper preparation and asked to repeat it for the rescheduling of the procedure, which was scheduled for (b)(6) 2024.On (b)(6) 2024, the patient returned to the clinic for the procedure.When asked about preparation, the patient reported consuming coca-cola one hour before the procedure.The need for proper preparation was reinforced, and it was explained that the procedure could not be performed that day due to non-compliance with the provided instructions.The procedure was rescheduled for (b)(6) 2024.On (b)(6) 2024, the patient was admitted to the clinic for the adjustment procedure.She claimed to have followed the preparation correctly, which consisted of four days of restricted liquid diet.Asked again, according to the clinic's protocol, about health problems and continuous medication use, the patient reported only anxiety and the use of sertraline 50mg.The examination began with the introduction of the endoscope, observing the stomach without any alterations and the balloon in a preserved state.During the balloon adjustment, at the end of the procedure, the patient experienced desaturation and required positive pressure ventilation due to bronchospasm, which occurred despite no complications being observed in the stomach during the procedure.After the procedure, the anesthesiologist spoke with the patient about the episode and asked about respiratory problems.The patient reported having had an asthma attack three days ago, apologizing for not mentioning it earlier.The doctors emphasized the need for the patient to seek asthma treatment.The anesthesiologist emphasized the importance of informing all health problems before any procedure, and the patient apologized to the attending doctors.After two hours of observation in the clinic, the patient was reassessed, with a blood pressure of 12/7 and oxygen saturation of 98% in ambient air.The doctors prescribed aerolin and administered a dose of three puffs in the clinic, instructing the patient to seek medical attention or contact the clinic if she experienced any symptoms.The next day ((b)(6) 2024) the patient reported abdominal pain to the nursing staff, and it was identified that she had consumed hamburger pieces and stroganoff broth contrary to the liquid diet instructions post-procedure.The nursing staff contacted the doctor, who requested that the patient go to the emergency room to be seen by an urgent care physician and undergo evaluation, considering that the doctor was attending in another municipality.Additionally, the doctor instructed the patient to inform the doctor to contact the physician who performed the procedure.After being admitted to the hospital the patient contacted the doctor by message.The doctor called the patient, who informed them that the doctor had performed an x-ray and reported that there was nothing abnormal in the image.It was also mentioned that tramadol and plasio were administered, and the patient was getting ready to leave the hospital, although she still felt pain.During the call, the doctor requested that the patient ask the doctor to perform a tomography.Immediately after leaving the emergency room, the patient returned to the clinic to receive intravenous therapy, including 500ml of saline, b complex, and dexamethasone.During this treatment, the patient's sister reported that she had consumed hamburger and stroganoff on the same day as the procedure, contrary to medical instructions for a liquid diet for 3 days.Therefore, avoiding solid foods after the intragastric balloon placement or adjustment procedure is essential to ensure patient safety and optimize treatment outcomes.The patient reported, still at the clinic, that she received a referral to undergo tomography on an outpatient basis, as the hospital did not consider the examination necessary.In the clinic, she received the medication mentioned above, resulting in symptom improvement.Vital signs in the clinic were recorded as follows: blood pressure: 130/90 mmhg heart rate: 74 bpm oxygen saturation: 99% capillary blood glucose: 192 mg/dl.The patient was instructed to monitor her blood glucose.After receiving instructions, the patient was again discharged home, with instructions to return to the emergency room if the pain persisted.In the same day afternoon, the patient called the doctor reporting pain, and the doctor asked her to return to the emergency room.At 9:00 pm on the same day, the doctor contacted and called the patient.The sister answered, and the doctor asked how she was.The sister reported that the patient was no longer feeling anything, that she had not gone to the emergency room, had taken medicine, and was even sleeping.At four o'clock in the morning the next day ((b)(6) 2024) the family contacted the doctor reporting that the patient had been sent to the hospital but had arrived there deceased.

• 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: 19077567
• MDR Text Key: 339773052
• Report Number: 3012638928-2024-03065
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 860005178810
• UDI-Public: (01)860005178810(11)2023-05-21(17)2025-05-21(10)230521
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/10/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: A-SP3-03K
• Device Lot Number: 230522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2023
• 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; Death
• Patient Sex: Female
• Patient Weight: 78 KG