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 Death (1802)

Event Date 11/20/2020

Event Type  Death  

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 se 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.The communications hub indicated ablations were performed with rf power of 45w.Review of the device history record was not possible as the lot number is unknown.The tacticath contact force ablation catheter, sensor enabled 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¿ and warns ¿too high rf power during ablation may lead to perforation caused by steam pop;¿ however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event.

Event Description

Following a vt ablation procedure, the patient passed due to a left ventricle rupture.During the procedure, a steam pop occurred that was thought to be due to the vt at the time.The patient became hypotensive during the procedure, and when checked using ice there was no effusion seen.Following the procedure an echocardiogram was performed which revealed a left ventricle rupture.Further information regarding the event is unable to be provided.There were no performance issues with any abbott devices.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11031787
• MDR Text Key: 222164581
• Report Number: 3005334138-2020-00598
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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
• Date Manufacturer Received: 11/24/2020
• 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): Death