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 Communication or Transmission Problem (2896); Electrical Shorting (2926)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

Analysis revealed a short circuit in the catheter.

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.Electrical testing revealed a short circuit between the magnetic sensor wires and the pull ring, consistent with the reported event.Dissection of the catheter revealed the magnetic sensor wires were wrapped around the fluid lumen underneath the pull ring within the distal shaft, and abrasion damage to magnetic sensor wire insulation was identified.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

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.

• 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; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17984609
• MDR Text Key: 326460691
• Report Number: 3005334138-2023-00483
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: 05415067034571
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: A-TFSE-DF
• Device Lot Number: 8728328
• 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: 10/26/2022
• 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