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 Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

Before to start of an atrial tachycardia procedure, the physician made the purge of the tacticath se and blood went to the tubulure of the tacticath se.The tacticath se was exchanged and the procedure was completed with on adverse patient consequences.

Event Description

Before the start of an atrial tachycardia procedure, the physician purged the tacticath se catheter and blood went to the tubular of the tacticath se catheter.The tacticath se catheter was exchanged, and the procedure was completed with on adverse patient consequences.The issue was an error of manipulation and not an issue of the catheter.The user did not connect the tubulure of the cool point pump before inserting the catheter inside the patient.

Manufacturer Narrative

One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.Per artmt600077636 ver.A tacticath contact force ablation catheter, sensor enabled instructions for use (ifu), the irrigation tubing is to be connected to the luer fitting of the catheter prior to insertion into the sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event is consistent with not following the instructions for use.

• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16302091
• MDR Text Key: 308915285
• Report Number: 3008452825-2023-00044
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 8771564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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