MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number A-TFSE-FJ

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

During a redo atrial fibrillation procedure in voxel mode, when the tactiflex ablation catheter was advanced out into the left atrium, it was discovered that the catheter was behaving incorrectly.The catheter appeared to be directed towards the right veins on ensite x, but on ice and fluoro it proved that the catheter was in fact pointing to the left veins.The vector arrow also was not showing up either.After trying to troubleshoot the catheter, a new one was opened and inserted and that proved to solve the vector arrow and directionality issue.No adverse patient consequences occurred.The case was successfully completed with the new tactiflex catheter.

Manufacturer Narrative

Fsca number: 3008452825-12/14/23-001-r.One bi-directional, curve f-j, tactiflex ablation catheter, sensor enabled was received for evaluation.The 10-pin eeprom was programmed with the incorrect model id number during manufacturing, consistent with the catheter being read as a flexability curve dd when connected to ensite.

Manufacturer Narrative

Additional information: d9, g3, g6, h2, h3 corrected data: h6 one bi-directional, curve f-j, tactiflex ablation catheter, sensor enabled was received for evaluation.The 10-pin eeprom was programmed with the incorrect model id number during manufacturing, consistent with the catheter being read as a flexability curve dd when connected to ensite.

• 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, COSTA RICA LTDA; 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; 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: 18673632
• MDR Text Key: 334982808
• Report Number: 3008452825-2024-00080
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-TFSE-FJ
• Device Lot Number: 10086492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1