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

Model Number A-TCSE-DF

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event Description

Related manufacturing ref: 3005334138-2020-00454, 3008452825-2020-00505.Following the procedure, the patient experienced transient ischemic attack (tia) symptoms.During the ablation procedure, signal artifact was observed on the distal signal during ablation.The catheter was used to complete the procedure and no symptoms were noted following the procedure.The patient experienced blurred vision on september 5th, and 6th.Imaging was conducted to identify a possible tia but revealed no anomalies.Transesophageal echo was performed prior to the procedure to rule out thrombus.There were no performance issues with the devices.

Manufacturer Narrative

An event of a transient ischemic attack (tia) and noise was reported.The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.A review of the device history record (dhr) was not possible as no lot number was provided.Based on the information received, the cause of the reported tia could not be conclusively determined.

• Brand Name: TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F
• 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: 10642609
• MDR Text Key: 210214619
• Report Number: 3005334138-2020-00453
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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 Model Number: A-TCSE-DF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD GRID; AGILIS INTRODUCER; ADVISOR HD GRID; AGILIS INTRODUCER
• Patient Outcome(s): Other