MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number A-TCSE-D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Cardiac Perforation (2513)

Event Date 05/17/2023

Event Type  Injury  

Event Description

During an atrial fibrillation procedure, a pericardial effusion was confirmed.At the end of the procedure, after ablation was completed in the left atrium, the effusion was diagnosed with a viewflex ice catheter.It is unknown, what caused the effusion, but it is suspected that it occurred near the left atrium roof close to the laa while trying to check for block along the waca ablation lines and high force was seen on the tacticath se ablation catheter (over 100g of force).To treat the pericardial effusion, the fluid around the heart was drained and the viewflex ice catheter was used to see how much fluid was left around the heart.The procedure was completed and the patient is stable.There were no alleged performance issues with any of the devices.

Manufacturer Narrative

One uni-directional, curve d, tacticath sensor enabled contact force ablation catheter 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 with no error messages noted.The magnetic sensor, both thermocouples, and electrodes 1-4 met specifications during electrical testing with no open or short circuits detected.In addition, the device met specifications during temperature testing and irrigation flow testing.The catheter shaft deflected when the steering mechanism was actuated and met specifications for curve shape.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported pericardial effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

During an atrial fibrillation procedure, a pericardial effusion was confirmed.At the end of the procedure, after ablation was completed in the left atrium, the effusion was diagnosed with a viewflex ice catheter.It is unknown, what caused the effusion, but it is suspected that it occurred near the left atrium roof close to the laa while trying to check for block along the waca ablation lines and high force was seen on the tacticath se ablation catheter (over 100g of force).To treat the pericardial effusion, a pericardiocentesis was performed with drainage of 1600 cc of fluid.The patient was transferred to the icu, where 2 units of prbcs were transfused.The procedure was completed and the patient is stable.There were no alleged performance issues with any of the devices.On (b)(6) 2023 that the patient had a transient ischemic attack likely as a result of the pericardial effusion event, later confirmed by additional cranial imaging.After extubation, the patient showed dysarthria and right upper extremity weakness.A brain mri showed acute infarct.Neurology then cleared the patient and anticoagulation was resumed, he was then transferred to the floor and deemed stable for discharge.The patient has recovered upper extremity movement and improvements in speech.The attending physician notes complete recovery and that the patient is in stable condition.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 17025521
• MDR Text Key: 316202156
• Report Number: 3008452825-2023-00223
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027689
• UDI-Public: 05415067027689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: A-TCSE-D
• Device Catalogue Number: A-TCSE-D
• Device Lot Number: 8613752
• 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: 05/17/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 06/14/2023; 07/13/2023
• Supplement Dates FDA Received: 07/13/2023; 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 100 KG