MAUDE Adverse Event Report: SPATZ FGIA INC. SPATZ3 ADJUSTABLE BALLOON SYSTEM; A-SP3US-03S

Model Number A-SP3US-03K

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Nausea (1970); Vomiting (2144); Syncope/Fainting (4411)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

The balloon was not returned for examination.A review of the device labelling 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.Additional information regarding this late medwatch report- the firm was not aware that reports reported to fda under clinical setting should also be reported as a medwatch report.Capa was issued and procedures were updated, and qa dep.Was retrained.

Event Description

Subject presented to the emergency room 2 days after a down adjustment with dark stools and fainting episode.The patient was admitted to the hospital for 2 days.The dark stools ceased, and the patient's hemoglobin did not drop and did not require blood transfusion.The patient was discharged and requested an elective balloon removal, which was performed a week later.

Manufacturer Narrative

The balloon was not returned for examination.This report was updated to a second version following the clinical monitoring for the site 5, the clinical monitor had noticed that the patient number that we received initially was mistakenly reported.This summary report and the webtrader notification report were updated with the relevant/correct information of the patient.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.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.In the setting of suspected upper gi bleeding, guaiac of vomitus and stool, serial cbcs and endoscopic evaluation is advised.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.

Event Description

Patient presented to the er with nausea, vomiting, diarrhea and syncopal episode.Dark melanic stools were noted.Mild anemia, no blood transfusion.Discharged 3 days later and had elective balloon removal.Symptoms resolved with iv hydration prior to hospital discharge.

• Brand Name: SPATZ3 ADJUSTABLE BALLOON SYSTEM
• Type of Device: A-SP3US-03S
• Manufacturer (Section D): SPATZ FGIA INC.; 1801 s perimeter rd, suite 130; fort lauderdale; florida FL 33309
• Manufacturer (Section G): SPATZ FGIA INC.; 1801 s perimeter rd, suite 130; fort lauderdale; florida FL 33309
• Manufacturer Contact: pnina polishuk ; 1801 s perimeter rd, ste 130; fort lauderdale; fort lauderdale, FL 33309
• MDR Report Key: 15818866
• MDR Text Key: 303901947
• Report Number: 3012638928-2022-02690
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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 Expiration Date: 12/21/2023
• Device Model Number: A-SP3US-03K
• Device Catalogue Number: -
• Device Lot Number: 211221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 01/15/2024
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American