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

Model Number A-SP3-03K

Device Problems Inflation Problem (1310); No Apparent Adverse Event (3189)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

The patient got in touch to schedule an adjustment.At the time of the procedure, it was unable to adjust the balloon either higher or lower.

Manufacturer Narrative

The devcie was returned to spatz fgia inc.For analysis on 03/20/2024 and an evalaution was completed.The testing revealed a kink in the inflation tube.It seems that during the ballon implantation period, the inflation tube was kinked for a long period of time, which caused the inflation tube to be blocked.This blockage did not allow the doctor to adjust the balloon.The complaint description specified a complication with inflation tube during the adjustment procedure.A review of the device labelling notes that endoscopy and inspection check should be performed for balloon or inflation tube to detect any leakage and never inflate/deflate without endoscopic view of the inflation tube.

Event Description

The patient got in touch to schedule an adjustment.At the time of the procedure, it was unable to adjust the balloon either higher or lower.

Manufacturer Narrative

The devcie was returned to spatz fgia inc.For analysis on 03/20/2024 and an evalaution was completed.The testing revealed a kink in the inflation tube.It seems that during the ballon implantation period, the inflation tube was kinked for a long period of time, which caused the inflation tube to be blocked.This blockage did not allow the doctor to adjust the balloon.The complaint description specified a complication with inflation tube during the adjustment procedure.A review of the device labelling notes that endoscopy and inspection check should be performed for balloon or inflation tube to detect any leakage and never inflate/deflate without endoscopic view of the inflation tube.

• 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: 18966412
• MDR Text Key: 338452461
• Report Number: 3012638928-2024-03037
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 860005178810
• UDI-Public: (01)860005178810(11)2023-03-16(17)2025-03-16(10)230316
• 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: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/24/2024

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: 230316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/24/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/28/2024
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 69 KG