MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-D; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Model Number A-TCSE-DD

Device Problem Fracture (1260)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

One bi-directional, curve d-d, tacticath sensor enabled contact force ablation catheter was received for evaluation.Investigation revealed that the catheter shaft material had been fractured between electrode rings 2 and 3.Optical fiber 1 and the deformable body thermocouple (tc2) were determined to be fractured at the location of the fracture in the shaft material, consistent with the observed error messages, the detected open circuit, and with the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of this device deficiency was determined to be damage to the catheter tip during removal of the catheter from its packaging due to the design of the tip protector.

Event Description

This report is to advise of a fracture that was noted during analysis.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-D
• 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: 18358071
• MDR Text Key: 331208656
• Report Number: 3008452825-2023-00566
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027634
• UDI-Public: 05415067027634
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-TCSE-DD
• Device Lot Number: 9147673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• 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