MAUDE Adverse Event Report: ABBOTT MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Model Number	A-TFSE-DF
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a fractured and detached tip found in the catheter during investigation.
Additional Manufacturer Narrative
One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.The flex tip of the catheter was received with the tip was fractured and detached.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause was determined to be removal of the catheter from its packaging.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Manufacturer (Section D): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23837781
• Report Number: 3008452825-2025-00633
• Device Sequence Number: 20100659
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: (01)05415067034571(10)10852842(17)280430
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P220013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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-DF
• Device Catalogue Number: A-TFSE-DF
• Device Lot Number: 10852842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3008452825-08/27/25-001-
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Unknown
• Patient Weight: 149 KG