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 Perforation of Esophagus (2399)

Event Date 09/07/2021

Event Type  Injury  

Event Description

The patient had an atrial fibrillation isolation ablation procedure on (b)(6) 2021 with light sedation and was discharged home the following day without issue.On (b)(6) 2021, the patient presented to the hospital with a fever and episodes of dyspnea.An atrial/esophageal fistula was diagnosed in the posterior wall, left side, in the posterior division, between the superior and inferior pulmonary veins.And in the antral posterior wall.The patient was taken to surgery for repair of the fistula on september 9 and remains in the post surgery care unit.There were no performance issue about any abbott devices.

Event Description

The patient had an atrial fibrillation isolation ablation procedure on (b)(6) 2021 with light sedation and was discharged home the following day without issues.

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 tacticath catheter performed as intended.The optical fibers met specifications, the recorded temperatures indicated cooling during rf ablation, and contact force measurements were displayed throughout the duration of the log files.Force measurements were recorded during ablation that exceeded the recommended values in the tacticath se contact force ablation catheter instructions for use (ifu); however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported atrioesophageal fistula remains unknown.

• 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
• 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: 12467510
• MDR Text Key: 271266240
• Report Number: 3005334138-2021-00588
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/18/2021

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
• Device Catalogue Number: A-TCSE-DF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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