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 Optical Problem (3001)

Patient Problems Vascular Dissection (3160); Heart Block (4444)

Event Date 01/09/2024

Event Type  Injury  

Event Description

During a left ventricular outflow tract (lvot) ventricular tachycardia (vt) procedure, a small femoral vessel dissection and a heart block occurred.The dissection did not require intervention while the heart block required a temporary pacemaker placed.While advancing the catheter up the femoral, high forces were noted and there was some difficulty with advancing the catheter.The catheter was eventually successfully advanced to the aortic arch and this is where the force display began to fail.No force was displayed intermittently and when it was displayed it appeared to be inaccurately high.A small dissection of the femoral vessel was observed near the level of the common iliac after these high forces were noted.Troubleshooting steps were taken including removing the catheter and re-zeroing, readvancing the catheter, unplugging and plugging the catheter back in but these did not resolve the issue.The catheter was exchanged which resolved the issue and the procedure was completed successfully.Staff believe the dissection was likely done by the ablation catheter.Post procedure, it was also reported that the patient experienced heart block which required temporary pacemaker placement.Conduction returned and the pacemaker was removed.The patient was discharged from the hospital (b)(6) 2024.

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.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.The device met specifications during temperature testing, occlusion testing, and leak testing.Electrodes 1-4, both thermocouples, and the magnetic sensor met specifications during electrical testing with no open or short circuits detected, and the senor polarity orientation met specifications.In addition, the catheter was able to pass force accuracy testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported issue 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; 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: 18511872
• MDR Text Key: 332893819
• Report Number: 3005334138-2024-00014
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: 05415067034571
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: A-TFSE-DF
• Device Lot Number: 9055068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• 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 Outcome(s): Required Intervention; Life Threatening