MAUDE Adverse Event Report: ST. JUDE MEDICAL. TACTIFLEX SENSOR ENABLED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-TFSE-FJ
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ablation catheter stopped flushing/removed catheter and opened new ablation catheter.New catheter worked perfectly.

• Brand Name: TACTIFLEX SENSOR ENABLED
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL.; 5050 nathan ln n; plymouth MN 55442
• MDR Report Key: 21676063
• Report Number: 21676063
• Device Sequence Number: 7600264
• Product Code: OAE
• UDI-Device Identifier: 05415067034618
• UDI-Public: (01)05415067034618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/20/2025
• Report Date (Section F): 03/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: A-TFSE-FJ
• Device Catalogue Number: A-TFSE-FJ
• Device Lot Number: 10558450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Date Report Sent to FDA: 03/20/2025