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

Model Number A-SP3US-03K

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 06/25/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 the patient had egd with up adjustment of spazt 3 balloon 250 cc were added for a total volume of 700 cc.On (b)(6) 2023 patient reported moderate heartburn and nausea/vomiting.She had been discharged with omeprazole 40 mg bid for 14 days as per protocol and was told to take gaviscon q4h prn as well as zofran and hyosciamine.On (b)(6) 2023 patient started having muscle cramps including facial muscle cramps.She was instructed to come to receive iv hydration and labs but opted to visit an er center closer to her home and was given iv hydration and pepcid.Ct abd was unremarkable.Potassium level was low, and she was supplemented.The patient was admitted to the hospital for observation labs and imaging.Results not available at this time.

Manufacturer Narrative

"the balloon was not returned for examination.A review of the device labeling notes the following: the physician should also advise the patient that early removal of the balloon may be required due to intolerance or due to serious adverse events.It is the responsibility of the physician to advise the patient of the potential need to remove the device in less than 8 months due to balloon deflation.In the event of gastrointestinal intolerance, the physician may advise the patient to decrease balloon volume.It is important to discuss all possible complications and adverse events with the patient.Complications that may result from use of this product include those associated with general endoscopy procedures, those associated with the spatz3 adjustable balloon specifically and those associated with the patient's degree of intolerance to an implanted foreign body.Adverse health consequences resulting from weight loss such as gallstones, dehydration, loss of muscle mass, mood changes, electrolyte abnormalities, menstrual changes and nutritional deficiencies.Acute pancreatitis characterized by nausea, vomiting, abdominal pain, dehydration.The severity can range from mild to severe and may require balloon down adjustment, or removal.This may result in hospitalization, surgery or death in severe cases.".

• Brand Name: SPATZ FGIA INC.
• 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: 17387736
• MDR Text Key: 319752452
• Report Number: 3012638928-2023-02856
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 860005178803
• UDI-Public: (01)860005178803(11)2021-11-21(17)2023-11-21(10)211121
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/25/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2023
• Device Model Number: A-SP3US-03K
• Device Lot Number: 211121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2021
• 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): Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White