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 Optical Problem (3001)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

During a supraventricular radiofrequency ablation surgery, the catheter was unable to display pressure in the three-dimensional system, and the replacement of the light source was ineffective.At the request of the surgeon, the catheter was replaced, and the surgery proceeded with no consequences to the patient.However, this replacement caused a delay to the procedure.

Manufacturer Narrative

One bi-directional, curve d-d, tacticath sensor enabled contact force ablation catheter was received for evaluation.Visual inspection revealed the catheter had been bent 0.343¿ proximal to the distal tip, just distal to electrode ring 3.The shaft material and the internal tubing and wires within the shaft had been fractured at this location.Optical fiber 1 no longer met specifications for optical properties, and a thermocouple signal loss error and no contact force were displayed when the returned device was connected to the tactisys quartz unit.In addition, the deformable body thermocouple (tc2) read as an open circuit during electrical testing, consistent with the observed error message.Further 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 reported optical issue and subsequent delay.

• 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: 18328225
• MDR Text Key: 330544759
• Report Number: 3008452825-2023-00570
• 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,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 9188147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2023
• 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 Sex: Female