FDA Adverse Event Injury Summary report: N

TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

MDR report key: 24624359 · Received March 17, 2026

Report

Report Number: 3008452825-2026-00163
Event Type: Injury
Date Received: March 17, 2026
Report Date: March 17, 2026
Manufacturer: ABBOTT MEDICAL
Product Code: OAE
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

Description of Event or Problem · 0

THE FOLLOWING WAS PUBLISHED IN JOURNAL OF ARRHYTHMIA, PG. 191, 2025. WILEY. "FEASIBILITY AND EFFICACY OF 50W ABLATION WITH TACTIFLEX CATHETER IN INITIAL PULMONARY VEIN ISOLATION FOR ATRIAL FIBRILLATION"; KAZUHISA MATSUMOTO 100 AF PATIENTS WHO UNDERWENT ABLATION WITH TACTIFLEX WERE STUDIED. PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED WITH A 50W SETTING, A 5-20G CONTACT FORCE (CF), AND A 15-20 SECOND ENERGY DELIVERY. PRIMARY OUTCOMES INCLUDED THE SUCCESS OF PVI, FIRST-PASS ISOLATION (FPI), AND THE PRESENCE OF PV CONDUCTION GAPS. PATIENTS WERE FOLLOWED UP FOR 12 MONTHS AFTER PVI AND UNDERWENT MANDATORY ECG RECORDINGS AT 1, 3, 6, AND 12 MONTHS POST-PVI. A PERIESOPHAGEAL NERVE INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
515708	TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	OAE	ABBOTT MEDICAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Life Threatening