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

Model Number A-SP3-03K

Device Problems Patient-Device Incompatibility (2682); Air/Gas in Device (4062)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

The patient reports having nausea, vomiting and abdominal pain.The balloon was removed and replaced.

Manufacturer Narrative

The device was returned to spatz fgia inc.For analysis on 03/20/2024 and an evaluation was completed.The testing revealed some growth on the balloon's body.A review of the device labeling notes the following: spontaneous hyperinflation is the enlargement of the balloon with extra air that can occur spontaneously.This can lead to symptoms such as pain, nausea, vomiting, dehydration, ulceration, perforation, and could require a down adjustment or removal of the balloon.

• 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: 19009258
• MDR Text Key: 339053278
• Report Number: 3012638928-2024-03043
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• 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: 230521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 39 YR
• Patient Sex: Female
• Patient Weight: 100 KG