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

Model Number A-TCSE-DD

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

Patient Problems Stroke/CVA (1770); Paralysis (1997)

Event Date 09/15/2022

Event Type  Injury  

Event Description

After an atrial fibrillation procedure, the patient had a cerebral infarction in the afternoon of the same day, and as of the week of the 19th, the patient was still paralyzed, and the attending physician judged that the paralysis would remain.During the atrial fibrillation procedure, there were two times when the resistance exceeded 150 ohms during rf delivery and rf delivery was stopped, but there was no change in the patient's condition or vitals, and the act was appropriately controlled at about 300, and thrombus was not confirmed.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.The hospital discarded the reported catheter.

Event Description

After an atrial fibrillation procedure, the patient had a cerebral infarction in the afternoon of the same day, and as of the week of the 19th, the patient was still paralyzed in the lower body, and the attending physician judged that the paralysis would remain.During the atrial fibrillation procedure, there were two times when the resistance exceeded 150 ohms during rf delivery and rf delivery was stopped, but there was no change in the patient's condition or vitals, and the act was appropriately controlled at about 300, and thrombus was not confirmed.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.The hospital discarded the reported catheter.A transesophageal echocardiogram was performed preoperatively and there was no patient history of cva that could lead to thrombosis.

Manufacturer Narrative

An event of stroke was reported.The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.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 D-D
• 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: 15591458
• MDR Text Key: 301624861
• Report Number: 3005334138-2022-00549
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027634
• UDI-Public: 05415067027634
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130026
• 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: 11/03/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: A-TCSE-DD
• Device Catalogue Number: A-TCSE-DD
• Device Lot Number: 8310971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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): Disability