MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A-TFSE-DF

Device Problems Communication or Transmission Problem (2896); Optical Problem (3001)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

Manufacturing ref: 3008452825-2023-00578.During an atrial fibrillation procedure, it was noted that the catheter force jumped up to 40g continuously with no variation in the graph.The force was reset but the force jumped again.No tissue contact was confirmed, and the force remained around 40g with a flat graph.Then there was an intermittent message about the catheter being disconnected.The tactisys was exchanged but with no resolution.The catheter was exchanged for a second catheter of the same lot but with no resolution.The catheter was exchanged for a third catheter of a different lot and used with the original tactisys, and the issue was resolved.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3 one bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.Log file analysis indicated a manual reset was performed outside the patient and not after insertion into the patient.The auto reset function was carried out for a period of time to reset contact force values, however after multiple instances of forces being applied to the tip the auto reset function was no longer carried out and a check baseline messaged was displayed.The auto reset function has a cumulative limit to the amount of contact force reset that can be performed and if this limit is consumed the auto reset function will no longer be carried out without a manual reset being performed.The tactiflex ablation catheter sensor enabled instructions for use states "always zero the contact force reading following insertion into the patient or when moving the catheter from one chamber of the heart to another.Ensure the catheter is not in contact with heart tissue prior to zeroing.¿ additionally, the ensite x ep system contact force module instructions for use states "baseline operation should be checked regularly and if necessary reset to zero, especially under the following circumstances: after the first insertion of the catheter into the body.After reinsertion into the patient¿s body after retraction through a sheath.When the message 'check contact force baseline' displays¿" when the returned device was connected to the tactisys quartz unit, optical fibers 1-3 met specifications for optical properties and contact force was displayed and able to be reset to baseline values with no error messages noted and the deformable body thermocouple met specifications during electrical testing.In addition, the device met specifications during leak testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the contact force issue and subsequent delay is consistent with a user related issue.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 18366124
• MDR Text Key: 331074289
• Report Number: 3008452825-2023-00577
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: 05415067034571
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/16/2024

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
• Device Operator: Health Professional
• Device Model Number: A-TFSE-DF
• Device Lot Number: 9169030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2023
• 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
• Treatment: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿