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

Model Number A-TFSE-DF

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2023

Event Type  malfunction  

Event Description

This report is to advise of a displaced electrode and fracture in the conductor wire.

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.Electrode 2 read as an open circuit during electrical testing, consistent with the reported event.Further investigation revealed electrode ring 2 was shifted distally on the catheter shaft causing a fracture in conductor wire 2, consistent with the open circuit detected.The shaft outer diameter at electrode ring 2 was not within specifications, however this was determined to not have contributed to the shifted electrode ring or the fractured wire.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the shifted electrode ring and subsequent fracture remains unknown.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18721370
• MDR Text Key: 335584119
• Report Number: 3008452825-2024-00092
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P220013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: A-TFSE-DF
• Device Lot Number: 8955663
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 52 KG