MAUDE Adverse Event Report: GALT MEDICAL CORP. FLUENT MICRO-INTRODUCER KIT

Lot Number	G25134468
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Type of Reportable Event	Malfunction
Event or Problem Description
Angioplasty procedure.Micropuncture set used for angiography.During withdrawal of the 4f catheter, it broke into two pieces.The distal portion remained in the patient's right femoral artery, measuring approximately 10cm in length.This was able to be removed using a complex endovascular technique via contralateral (left) femoral artery access.

• Brand Name: FLUENT MICRO-INTRODUCER KIT
• Common Device Name: MICRO-INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220 merritt dr; garland 75041
• Manufacturer (Section G): GALT MEDICAL CORP.; 2220 merritt dr; garland TX 75041
• Manufacturer Contact: david derrick ; 2220 merritt dr; garland, TX 75041 ; 2147781306
• MDR Report Key: 24368210
• Report Number: 1649395-2025-00009
• Device Sequence Number: 5315335
• Product Code: OFL
• UDI-Device Identifier: 00841268104587
• UDI-Public: 00841268104587
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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 Lot Number: G25134468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown