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 05/18/2021

Event Type  Death  

Event Description

Related manufacturing ref: 3008452825-2021-00358.Post atrial fibrillation ablation procedure, the patient presented with an atrio-oesophageal fistula and expired.During the procedure, prior to right sided pulmonary vein ablation, the first catheter was unable to zeroed.Another catheter of the same type was obtained; however, the physician was not confident in the contact force numbers.A fistula was noted adjacent to the right inferior pulmonary vein and the patient expired.

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.Auto resets were regularly performed throughout the log files and contact force values of 25-50 grams were noted throughout the log files; however, due to unknown procedural conditions, we are unable to conclusively determine the cause of the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported atrio-oesophageal fistula and subsequent patient death remains unknown.

Event Description

Post atrial fibrillation ablation procedure, the patient presented with an atrio-oesophageal fistula and expired.During the procedure, prior to right sided pulmonary vein ablation, the first catheter was unable to zeroed.Another catheter of the same type was obtained; however, the physician was not confident in the contact force numbers.Twenty one days post procedure, the patient presented with non specific neurological symptoms.A ct scan was performed but fistula was not diagnosed at this point and it is believed the patient subsequently had another 2 ct scans after the initial.The fistula was diagnosed on the 3rd scan days later by which point the patients symptoms included arm weakness and possible cerebral event.Surgical repair of a fistula adjacent to the right inferior pulmonary vein and the patient later passed away.

• 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; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 12064357
• MDR Text Key: 258245971
• Report Number: 3008452825-2021-00357
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 7752711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death