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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon product investigation, the distal tip of the catheter was noted to be detached, however further information received from the field confirmed that the catheter was intact when it was removed from the patient.
Additional Manufacturer Narrative
One tactiflex ablation catheter, sensor enabled was received for evaluation.The flex tip had been fractured and detached.The tip was confirmed as being intact throughout the procedure and after removal from the patient.Although the root cause cannot be conclusively determined, it is possible the catheter was potentially damaged by the user during removal from the packaging due to interaction with the packaging design.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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 n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50408485
• Report Number: 3008452825-2026-00468
• Device Sequence Number: 21443650
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: (01)05415067034571(10)10666138(17)251231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P220013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: A-TFSE-DF
• Device Catalogue Number: A-TFSE-DF
• Device Lot Number: 10666138
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2026
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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 Sex: Unknown