MAUDE Adverse Event Report: ABBOTT MEDICAL TACTIFLEX SE F-CURVE ABLATION CATHETER; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Model Number	A-TFSE-F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During an atrial flutter procedure, while ablating the cavo-tricuspid isthmus (cti), a pressure induced perforation occurred which required surgery.The perforation was successfully repaired and the patient stabilized.A basal posterior perforation in the right ventricle was confirmed during surgery.The patient had a hyper-mobile and tortuous cti.There were no performance issues with any abbott device.

• Brand Name: TACTIFLEX SE F-CURVE ABLATION CATHETER
• 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 ; 6517565400
• MDR Report Key: 24198807
• Report Number: 3008452825-2026-00039
• Device Sequence Number: 9624751
• Product Code: OAE
• UDI-Device Identifier: 05415067034670
• UDI-Public: 05415067034670
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A-TFSE-F
• Device Catalogue Number: A-TFSE-F
• Was Device Available for Evaluation?: No
• 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: 01/05/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 46 KG