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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Stenosis (2263); Perforation of Esophagus (2399); Cardiac Perforation (2513)

Event Type  Death  

Event Description

Related manufacture ref: 3008452825-2023-00201.The following was published in the heart rhythm 20.5: 680-688.Elsevier b.V.(may 2023) in an article titled "very long term outcomes of atrial fibrillation ablation", winkle, roger.The purpose of this study was to evaluate very long term af ablation outcomes.Subjects were consecutive patients undergoing af ablation from (b)(6) 2003, to (b)(6) 2021.5200 patients were followed undergoing 7145 ablation procedures.We evaluated outcomes after single and multiple ablation procedures for paroxysmal (paf; 33.6%), persistent (peaf;56.4%), and long-standing (lsaf; 9.9%) af.We compared 3 ablation eras by initial ablation catheter: early (101 patients) using solid big tip (sbt) catheters (october 2003 to december 2005), intermediate (2143 patients) using open irrigated tip (oit) catheters (december 2005 to august 2016), and contemporary (2956 patients) using contact force (cf) catheters ((b)(6) 2014 to (b)(6) 2021) the following complications occurred: an atrioesophageal fistula resulting in death, a stroke resulting in death, tamponade (some requiring surgery and some requiring a pericardiocentesis) and pulmonary vein stenosis.

Manufacturer Narrative

Concomitant device: transseptal needle, brk series.

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 incidents remain unknown.

• 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: 16942004
• MDR Text Key: 315330197
• Report Number: 3005334138-2023-00206
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• 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: 06/15/2023
• 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