MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	402840
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing reference: 2030404-2024-00015.During an atrioventricular nodal reentrant tachycardia (avnrt) case, communication issues with the catheters resulted in a procedural delay.The catheter did not register on the ampere generator and no signals or proper display of the catheter was seen on the ensite x or on the non-abbott recording system (ge).All the connections were checked to ensure proper hook-up, the catheter connection cable was changed, the gen connect cable was changed, the generator was exchanged, the catheter was exchanged, and the system was power cycled.The issue was not resolved, the new catheter did not register in the generator as being connected and no signals or catheter display was seen.This second catheter was exchanged for a tacticath se ablation catheter and the issue was resolved.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One quadripolar, bi-directional, safire tx ablation catheter was received for evaluation.Electrodes 1-4 met specifications of acceptable resistance values with no open or short circuits detected.The catheter met specifications for thermocouple electrical testing and no error message was noted when the catheter was connected to the generator.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported connection and display issue remains unknown.

• Brand Name: SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18874800
• Report Number: 2030404-2024-00016
• Device Sequence Number: 20793253
• Product Code: OAD
• UDI-Device Identifier: 05414734300162
• UDI-Public: 05414734300162
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 08/31/2025
• Device Model Number: 402840
• Device Lot Number: 8620107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER.
• Patient Sex: Unknown