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

Model Number A-TCSE-FJ

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

Patient Problem Nerve Damage (1979)

Event Date 09/14/2023

Event Type  Injury  

Event Description

After a recent ablation procedure, the patient presented to the hospital for progressively worsening dyspnea and difficulty breathing.It is thought that patient's symptoms are possibly an injury to phrenic nerve injury from ablation procedure.The patient was hospitalized and acetaminophen and colchicine were administered.The patient is in stable condition.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Additional information: d9, g1, g3, h2, h3.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system were returned.The log file analysis concluded that the catheter performed as intended.The optical fibers met specifications while inside the patient, the recorded temperatures indicated cooling during rf ablation, and contact force measurements were displayed throughout the duration of the log files.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J
• 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: 17952674
• MDR Text Key: 325875028
• Report Number: 3008452825-2023-00466
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027665
• UDI-Public: 05415067027665
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-TCSE-FJ
• Device Lot Number: 9083432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 133 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White