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 Problem Abdominal Pain (1685)

Event Date 08/12/2022

Event Type  malfunction  

Event Description

A balloon was hyperinflated with severe abdominal discomfort in the patient.After endoscopic examination, it was decided to replace the balloon.

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: 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: 15594057
• MDR Text Key: 301628708
• Report Number: 3012638928-2022-02698
• Device Sequence Number: 1
• Product Code: LTI
• 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: 09/15/2022

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 Expiration Date: 02/16/2023
• Device Model Number: A-SP3-03K
• Device Lot Number: 210216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2021
• 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 Sex: Female
• Patient Weight: 115 KG