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

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/19/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 337406531
• Report Number: 2030404-2024-00016
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05414734300162
• UDI-Public: 05414734300162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402840
• Device Lot Number: 8620107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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
• Treatment: SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER.