MAUDE Adverse Event Report: ABBOTT MEDICAL 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 Codes	Communication or Transmission Problem (2896); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial flutter procedure, the catheter was not recognized by the system and could not deliver rf energy causing a delay in procedure.All hardware and software troubleshooting were done, with no resolution.The catheter was removed from the patient, and the tip of the catheter appeared bent and incorrect.The catheter was exchanged and there were no adverse patient health consequences.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.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 communication issue and subsequent delay 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): ABBOTT MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ABBOTT MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22344855
• Report Number: 2030404-2025-00024
• Device Sequence Number: 4825786
• Product Code: OAD
• UDI-Device Identifier: 05414734300162
• UDI-Public: (01)05414734300162(10)10774265(17)280229
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/27/2025

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 Model Number: 402840
• Device Catalogue Number: 402840
• Device Lot Number: 10774265
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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