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

Model Number A-TFSE-DF

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 12/07/2023

Event Type  Injury  

Event Description

During a typical atrial flutter procedure, a pericardial effusion occurred requiring a pericardiocentesis followed by cardiovascular surgery to repair the perforation and stabilize the patient.During ablation on cavo-tricuspid isthmus line set at 45w, the average contact force was (b)(4).The catheter dropped into a pouch and contact force reached (b)(4) and a steam pop occurred.No impedance rise was noted, but ablation was discontinued for that lesion immediately after the steam pop.Approximately 30 minutes after the steam pop, the patient became hypotensive and ice was used to confirm the effusion.The procedure was stopped and a pericardiocentesis was performed.The patient was then sent for surgery to repair the perforation and stabilize the patient.The patient is recovering in icu.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TACTIFLEX¿ 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: 18358550
• MDR Text Key: 330904581
• Report Number: 3005334138-2023-00564
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067034571
• UDI-Public: 05415067034571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220013
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-TFSE-DF
• Device Lot Number: 9245880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• 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): Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female