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 Problems Fracture (1260); Communication or Transmission Problem (2896); Electrical Shorting (2926)

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

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.A slight bend in the catheter shaft was noted 10¿ distal to the distal end of the handle.Electrical testing confirmed a short circuit between the magnetic sensor wires and the pull ring.Dissection of the catheter determined the magnetic sensor wires were wrapped around the fluid lumen underneath the pull ring and one of the sensor wire pairs was untwisted near the pull ring.Abrasion to the magnetic sensor wires under the pull ring as well as near the sensor coil was also detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

Analysis revealed a short circuit in the catheter.

Manufacturer Narrative

The investigation was reviewed and revealed a short circuit due to an abrasion in the magnetic sensor wire resulting in unintended electrical continuity between the magnetic sensor wires and the pull ring.This may result in unexpected voltage (noise) in the magnetic sensor in the presence of rf ablation resulting in a catheter freeze on the display screen.A short circuit located at this location in the catheter would not result in unintended ablation from a different location on the catheter.A review of complaint data shows that there have been no adverse events due to this issue however there have been delays to procedures.Based on this information, this is not considered a reportable malfunction.

Manufacturer Narrative

The investigation was reviewed and revealed a short circuit due to an abrasion in the magnetic sensor wire resulting in unintended electrical continuity between the magnetic sensor wires and the pull ring.This may result in unexpected voltage (noise) in the magnetic sensor in the presence of rf ablation resulting in a catheter freeze on the display screen.A short circuit located at this location in the catheter would not result in unintended ablation from a different location on the catheter.Based on this information, this is not considered a reportable malfunction.

Manufacturer Narrative

H6: correct code from fracture to short circuit.

• 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, COSTA RICA LTDA (AFD); 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: 17975091
• MDR Text Key: 326138236
• Report Number: 3008452825-2023-00480
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: 05415067034571
• 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,Followup,Followup,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: A-TFSE-DF
• Device Lot Number: 8825900
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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