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

Model Number A-SP3-03K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aspiration/Inhalation (1725)

Event Date 05/11/2022

Event Type  Injury  

Manufacturer Narrative

To date, spatz fgia inc.Has not received the product for evaluation, therefore no analysis or testing has been done.According to the description provided by the distributor, the device was intact in the stomach and fully inflated.A review of the device labeling notes the following: complications related to the endoscopy procedure: abdominal cramps and discomfort from the air used to distend the stomach; sore or irritated throat following the procedure; aspiration of stomach contents into the lungs; cardiac or respiratory arrest (these are extremely rare and are usually related to severe underlying medical problems); digestive tract injury or perforation; upper digestive tract bleeding.

Event Description

The patient was scheduled for routine adjustment of an intragastric balloon via gastroscopy.On initial visualization of the intragastric balloon in the stomach, it was noted that there was a moderate amount of food in the stomach proximal to the intragastric balloon.The planned adjustment procedure was abandoned as the intragastric balloon tubing connector could not be located.The patient was transferred to the recovery ward and subsequently aspirated some of the food that was in the stomach.The patient's airway was cleared of the aspirated material, had an endotracheal tube placed, and was transferred to intensive care for observation.

• 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 FL 33309
• MDR Report Key: 14641509
• MDR Text Key: 293636772
• Report Number: 3012638928-2022-02585
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 860005178810
• UDI-Public: (01)860005178810(17)2024-02-10(10)220210
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other
• Type of Report: Initial
• Report Date: 05/15/2022

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?: No
• Device Expiration Date: 02/10/2024
• Device Model Number: A-SP3-03K
• Device Lot Number: 220210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2022
• 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: 44 YR
• Patient Sex: Female