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

Model Number A-SP3-03K

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

The doctor wanted to fill the balloon with liquid, but only a small part of liquid went into the balloon, the bigger part went into the patient's stomach.

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 use of the spatz3 adjustable balloon system include: balloon deflation and subsequent replacement.

Manufacturer Narrative

The device was returned to spatz fgia inc.For analysis on 11/26/2023 and an evaluation was completed.The testing revealed a linear cut at the inflation tube area that probably was caused during the implantation procedure.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 use of the spatz3 adjustable balloon system include: balloon deflation and subsequent replacement.

Event Description

The doctor wanted to fill the balloon with liquid, but only a small part of liquid went into the balloon, the bigger part went into the patient's stomach.

• 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: 18138497
• MDR Text Key: 328241545
• Report Number: 3012638928-2023-02931
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 860005178810
• UDI-Public: (01)860005178810(17)2024-08-10(10)220810
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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,Followup
• Report Date: 11/15/2023

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: 220810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 12/12/2023
• 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