MAUDE Adverse Event Report: ABBOTT MEDICAL, COSTA RICA LTDA 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	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During left ventricle ablation for ventricular tachycardia, the ablation catheter had gotten caught on some chordae requiring some maneuvering to remove it.The ampere generator and remote both read as 'catheter not connected'.We were still able to read internal egms, pace, and receive contact force.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.After the procedure concluded the catheter was inspected and the tip was no longer attached on the end.Both the physician and the fellow were informed that the tip had detached.It was suspected that the tip did not detach while inside the patient, egm reading and contact force were still displayed during removal of the catheter.There was no mention of removal difficulty while removing the catheter via the introducer.No foreign body was noted on fluoro during the incident.There are no reported adverse consequences to the patient.
Additional Manufacturer Narrative
One tactiflex ablation catheter, sensor enabled was received for evaluation.The flex tip had been fractured and detached, after entanglement.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, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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: 24475085
• Report Number: 3008452825-2026-00091
• Device Sequence Number: 10332254
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: (01)05415067034571(10)10929640(17)280531
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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 Model Number: A-TFSE-DF
• Device Lot Number: 10929640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• 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: 10/06/2025
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White