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

Model Number A-SP3-03K

Device Problems Deflation Problem (1149); Migration or Expulsion of Device (1395)

Patient Problem Constipation (3274)

Event Date 05/12/2023

Event Type  malfunction  

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: each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed to report to physicians immediately regarding any and all change of symptoms.Symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur should be reviewed with patient, and patients should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients reporting loss of satiety, increased hunger and/or weight gain should be examined radiographically and/or endoscopically, as this is indicative of a balloon deflation.It is necessary to replace a balloon which has spontaneously deflated.Complications- possible complications of the spatz3 adjustable balloon system include: balloon deflation and subsequent replacement.

Event Description

On (b)(6) 2023 the balloon came out with stool, the patient felt minor constipation then the tube came out and she pulled it out along with the balloon.The patient had down adjustment to 400 ml on (b)(6) 2022.

• 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: 17297013
• MDR Text Key: 318883618
• Report Number: 3012638928-2023-02845
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 860005178810
• UDI-Public: (01)860005178810(17)2024-07-10(10)220710
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-SP3-03K
• Device Lot Number: 220710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/11/2023
• 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 Sex: Female