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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 03/15/2022

Event Type  Injury  

Event Description

During a cti line in the right atrium, following an atrial fibrillation pulmonary vein isolation ablation procedure on the left side, a tamponade occurred following a steam pop during the last few ablations.The patient underwent a thoracotomy to repair the tamponade and has recovered after a successful surgery.There were no performance issues with the catheter.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The files provided were unable to be analyzed.The event description indicated ablations were performed with an rf power of 40-50 w with an irrigation flow of 17 ml/min.The tacticath sensor enabled contact force ablation catheter instructions for use (ifu) warns that ¿application of rf energy at a power higher than 30w is associated with a higher likelihood of audible steam pop occurrence.¿ in addition, the ifu recommends a minimum irrigation flow of 30 ml/min during ablations using power settings greater than 30 w; however, due to unknown procedural conditions, we are unable to conclusively determine the cause of the steam pop and tamponade.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿
• 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: 13862389
• MDR Text Key: 287696758
• Report Number: 3005334138-2022-00257
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2022
• 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