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

Model Number A-SP3-03K

Device Problem Air/Gas in Device (4062)

Patient Problem Abdominal Pain (1685)

Event Type  malfunction  

Event Description

An 11 months spatz balloon was removed from a patient.It was removed due to hyperinflation.

Manufacturer Narrative

Spatz has not received the product for evaluation.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, suite 130; fort lauderdale; florida FL 33309
• Manufacturer (Section G): SPATZ FGIA INC.
• Manufacturer Contact: pnina polishuk
• MDR Report Key: 15930273
• MDR Text Key: 305263877
• Report Number: 3012638928-2022-02735
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P190012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-SP3-03K
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: No
• 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