MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	A-TFSE-DD
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 3005334138-2024-00009, 3005334138-2024-00011 during an atrial fibrillation procedure, when the tactiflex ablation catheter (lot: 9066884) was connected, the electric potentials were displayed properly, but the sensors was not recognized at all.The tactiflex ablation catheter was reconnected three times, and the catheter presets were reloaded, and recreated from the nominal, but with no resolution.The ensite x system was restarted two times, the amplifier and the display workstation were also restarted at the same time, but with no resolution.When the tactiflex ablation catheter (lot: 9066884) was replaced with a 2nd it (lot: 9096966), the se issue was resolved.The second tactiflex ablation catheter(lot: 9096966) was working properly at first.However, approximately 20 minutes later, the output control was activated even though the temperature was lower, around 38 degrees c, than the setting value of tempguard, 42 dgrees c.The output only increased to 30 watts rather than the set value, 50 watts.When the 2nd tactiflex ablation catheter (lot: 9096966) was replaced with a 3rd it (lot: 9096966), the output issue was resolved.The third tactiflex ablation catheter (lot: 9096966) was working properly at first.However, about 10 minutes later, the temperature control was activated at around 37 degrees c, and the output did not increase to the set value.The third tactiflex ablation catheter was replaced with a fourth (lot: 9096966) and the procedure was completed with no adverse consequences to the patient.The hospital discarded the reported catheters.
Additional 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 ablation output issue could not be conclusively determined.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 18490465
• Report Number: 3005334138-2024-00010
• Device Sequence Number: 3666238
• 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
• Report Date (Section B): 01/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: A-TFSE-DD
• Device Lot Number: 9096966
• Was Device Available for Evaluation?: No
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 01/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTIFLEX ABLATION CATHETER SE; TACTIFLEX ABLATION CATHETER SE
• Patient Sex: Unknown