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-D-CLIN

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On 30sep20 abbott was notified that on (b)(6) 2020, during a left superior pulmonary vein (lspv) ablation procedure, a steam pop and pericardial effusion occurred.As rf was applied on the top left superior pv for around 9 seconds, the patient suddenly took a deep breath which led to a steam pop.A transthoracic echocardiogram was performed at that time, revealing a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.

Manufacturer Narrative

One uni-directional, curve d, tactiflex ablation catheter, sensor enabled (g5) was received for evaluation.Electrodes 1-4, both magnetic sensors, and both thermocouples met specifications during electrical testing.Optical fibers 1-3 met specifications for optical properties and contact force was displayed when connected to the tactisys quartz unit, with no error messages noted.In addition, the device met specifications during temperature testing, flow rate testing, and leak testing.The ensite case study was reviewed.Force measurements exceeded the recommended parameters of force during ablation, and lesion times were applied at the chosen power that exceeded the recommended maximum lesion time for that wattage, per the tactiflex catheter instructions for use (ifu) arten600082016.Per the event description and the review of the case study, the steam pop was determined to be procedurally related.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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
• MDR Report Key: 10732981
• MDR Text Key: 212970175
• Report Number: 3005334138-2020-00467
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: A-TFSE-D-CLIN
• Device Lot Number: 7596559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR