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 07/18/2023

Event Type  Injury  

Event Description

Five weeks post ablation procedure, the patient presented to the emergency room where a small atrial esophageal fistula was diagnosed, and a stent was placed.The patient had an atrial fibrillation ablation procedure on (b)(6) which was completed with no apparent complications and the patient was discharged to home.On (b)(6), the patient presented to an outlying emergency room with complaints of fever, chills and general malaise.A ct of the chest revealed a small atrial esophageal fistula.The patient was transferred to a third hospital and had an esophageal stent placed to repair the fistula and the patient is currently recovering.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported atrial esophageal 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: 17442175
• MDR Text Key: 320213543
• Report Number: 3005334138-2023-00339
• Device Sequence Number: 1
• Product Code: OAE
• 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
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2023
• 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
• Patient Sex: Male