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

Model Number A-SP3-03K

Device Problems Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)

Patient Problems Laceration(s) (1946); Perforation of Esophagus (2399)

Event Date 06/01/2023

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.A review of the device labeling notes the following: proper positioning of the spatz3 adjustable balloon system® within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or esophageal rupture.The physiological response of the patient to the presence of the spatz3 adjustable balloon system® may vary depending upon the patient's general condition and the level and type of activity.The complication section refers to: esophageal obstruction.Once the balloon has been inflated in the stomach, the balloon could be pushed back into the esophagus.If this occurs, surgery or endoscopic removal could be required.Injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding or even perforation, which could require a surgical correction for control.Injury to teeth, tissue in the oral cavity or throat and upper esophageal sphincter.".

Event Description

The initial complaint received from the patient on 19/06/2023: according to the patient she had the implantation on (b)(6).There was no intercurrence regarding the passage to the stomach.During balloon inflation, the tube between the valve and the balloon ruptured so that the balloon remained attached to the endoscope.Upon removal, there was a lesion in the cervical esophageal wall of approximately 2.5 cm cricopharyngeal.Complete closure of the lesion was performed with endoscope clips.After the incident, she was taken to the hospital where she was hospitalized for 7 days.Only on the 6th day of hospitalization was a tube passed to feed her, a tube that even after hospital discharge, she had to stay for another 6 days with a tube at home.The patient mentioned that she didn't have side effects that would compromise her life in the future.

Manufacturer Narrative

"to date, spatz fgia inc.Has not received the product for evaluation, therefore no analysis or testing has been done.Following the investigation carried out on the subject by the clinical director it was found that this was a case of esophageal mucosal tear.A review of the device labeling notes the following: proper positioning of the spatz3 adjustable balloon system® within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or esophageal rupture.The physiological response of the patient to the presence of the spatz3 adjustable balloon system® may vary dependingupon the patient's general condition and the level and type of activity.The complication section refers to: esophageal obstruction.Once the balloon has been inflated in the stomach, the balloon could be pushed back into the esophagus.If this occurs, surgery or endoscopic removal could be required.Injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding or even perforation, which could require a surgical correction for control.Injury to teeth, tissue in the oral cavity or throat and upper esophageal sphincter.".

Event Description

The initial complaint received from the patient on (b)(6) 2023: according to the patient she had the implantation on (b)(6).There was no intercurrence regarding the passage to the stomach.During balloon inflation, the tube between the valve and the balloon ruptured so that the balloon remained attached to the endoscope.Upon removal, there was a lesion in the cervical esophageal wall of approximately 2.5 cm cricopharyngeal.Complete closure of the lesion was performed with endoscope clips.After the incident, she was taken to the hospital where she was hospitalized for 7 days.Only on the 6th day of hospitalization was a tube passed to feed her, a tube that even after hospital discharge, she had to stay for another 6 days with a tube at home.The patient mentioned that she didn't have side effects that would compromise her life in the future.

• 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: 17348808
• MDR Text Key: 319283955
• Report Number: 3012638928-2023-02854
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P190012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-SP3-03K
• Device Lot Number: 221216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female