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-DD
Medical Device Problem Codes	Fracture (1260); Communication or Transmission Problem (2896); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a short circuit noted during analysis.
Additional Manufacturer Narrative
One bi-directional, curve d-d, tactiflex ablation catheter, sensor enabled was received for evaluation.Electrical testing revealed a short circuit between the magnetic sensor wires and the pull ring, consistent with the reported event.Dissection indicated the magnetic sensor wires were wrapped around the fluid lumen underneath the pull ring within the distal shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Additional Manufacturer Narrative
The investigation was reviewed and revealed a short circuit due to an abrasion in the magnetic sensor wire resulting in unintended electrical continuity between the magnetic sensor wires and the pull ring.This may result in unexpected voltage (noise) in the magnetic sensor in the presence of rf ablation resulting in a catheter freeze on the display screen.A short circuit located at this location in the catheter would not result in unintended ablation from a different location on the catheter.A review of complaint data shows that there have been no adverse events due to this issue however there have been delays to procedures.Based on this information, this is not considered a reportable malfunction.
Additional Manufacturer Narrative
The investigation was reviewed and revealed a short circuit due to an abrasion in the magnetic sensor wire resulting in unintended electrical continuity between the magnetic sensor wires and the pull ring.This may result in unexpected voltage (noise) in the magnetic sensor in the presence of rf ablation resulting in a catheter freeze on the display screen.A short circuit located at this location in the catheter would not result in unintended ablation from a different location on the catheter.Based on this information, this is not considered a reportable malfunction.
Additional Manufacturer Narrative
H6: correct code from fracture to short circuit.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: 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, COSTA RICA LTDA (AFD); 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: 17977201
• Report Number: 3008452825-2023-00482
• Device Sequence Number: 3518261
• Product Code: OAE
• UDI-Device Identifier: 05415067034557
• UDI-Public: 05415067034557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P220013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: A-TFSE-DD
• Device Lot Number: 8834157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 10/20/2023; 10/20/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 10/20/2023; 11/07/2023; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown