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

Model Number A-SP3US-03K

Device Problem Deflation Problem (1149)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

Balloon leak at time of placement.

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: intestinal obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.Death due to intestinal obstruction is possible and has been reported with intragastric balloons.Patients experiencing any symptoms of an intestinal obstruction (e.G., acute onset of abdominal pain, nausea or vomiting) should be advised to seek immediate care.The labeling refers also to the possibility of a hole in the balloon prior/during implantation the maximum placement period for the spatz3 adjustable balloon is 8 months.The risk of intragastric balloon deflation and intestinal obstruction (and therefore possible emergency surgical intervention and death), ulceration and gastric perforation is significantly higher when balloons are left in place longer than 8 months.The presence of blue-green urine or sudden loss of satiety, increased hunger and/or weight gain may be a sign of balloon deflation.Patients should be instructed to immediately contact their physician if they observe any of these signs.Clinical means of assessing possible deflation include abdominal x-ray, ultrasound, barium swallow, cat scan and endoscopy.In some cases, the balloon can be vomited or passed in a bowel movement.If the deflated balloon passes into the intestine, it could result in intestinal obstruction requiring surgery.If the balloon is vomited, patients can experience laryngospasm, hypoxia, esophageal injury, and pulmonary aspiration.Patients may not observe or report the presence of blue-green urine following a balloon deflation.Patients should be advised to seek immediate care if any symptoms of an intestinal obstruction such as acute abdominal pain, nausea or vomiting develop.Deflated balloons must be removed promptly.The risk of intestinal obstruction (and therefore possible emergency surgical intervention and death) is significantly higher when deflated devices are not removed promptly.Balloons can develop surface colonization known as biofilm.For example, the rate in brazil is 14.9% of intragastric balloons.In the us pivotal study, 1/187 spatz3 adjustable balloons deflated with the presence of surface biofilm.While biofilm colonization of the balloon surface usually is without sequelae, it can negatively affect the balloon integrity leading to balloon deflation and rarely, bowel obstruction requiring surgery.It is the responsibility of the physician to advise the patient of known risks and complications associated with the procedure and the device.It is the responsibility of the physician to advise the patient of the potential need to remove the device in less than 8 months due to balloon deflation.In the event of gastrointestinal intolerance, the physician may advise the patient to decrease balloon volume.Each patient must be monitored closely during the entire term of treatment to detect the development of possible complications.Each patient should be instructed regarding signs and symptoms of balloon deflation, gastrointestinal obstruction, perforation, ulceration and other complications, which might occur, and should be advised to contact his/her physician immediately upon the onset of such signs and symptoms.Any change in symptoms - new onset nausea, vomiting, pain, or trouble breathing - needs to be addressed by the doctor.The cause may include dietary indiscretion, ulceration, hyperinflation, perforation or obstruction.In certain circumstances the doctor will choose to do an x-ray, or endoscopy, if dietary/medication changes do not alleviate symptoms.Prompt attention is recommended to prevent serious complications.".

Manufacturer Narrative

The device was returned to spatz fgia inc.For analysis on 12/25/2023 and an evaluation was completed.The testing revealed a hole in the balloon's body which caused the deflation.A review of the device labelling 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 adustable balloon system include: balloon deflation and subsequent replacement.

Event Description

Balloon leak at time of placement.

• 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: 18316948
• MDR Text Key: 330329962
• Report Number: 3012638928-2023-02944
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 860005178803
• UDI-Public: (01)860005178803(11)2023-02-21(17)2025-02-21(10)230221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-SP3US-03K
• Device Lot Number: 230221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2023
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 107 KG