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	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing reference: (b)(4).  during an av node ablation procedure, impedance issues required multiple troubleshooting measures without resolving the issue and the procedure was cancelled with no adverse consequences to the patient.It was noted that the ablation catheter was not delivering energy due to "impedance out of range" error on the ampere.The impedance was around 48-50ohms.We had two grounding pads on the patient located on his left scapula and second one underneath.We changed cables (both were reprocessed), but the issue was not resolved.We changed the location of the grounding pads, one left foot and one on the back but still could not ablate.The catheter was exchanged but the same issue occurred so we used two grounds on the legs to increase impedance up to 68-70 ohms.We were able to deliver energy from ampere but nothing was happening regarding ablating the av node so the physician decided to stop because we weren't sure of the amount of energy delivery nor where it is going.Patient status is good and the procedure will be rescheduled.
Additional Manufacturer Narrative
One quadripolar, bi-directional, safire tx ablation catheter was received for evaluation.Microscopic inspection of the tip electrode revealed no anomalies.The catheter deflected when actuating the steering mechanism.The catheter successfully attached to a test box with no anomalies noted.Electrode 1 met specifications for acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported impedance 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: 18582499
• Report Number: 2030404-2024-00004
• Device Sequence Number: 8517726
• Product Code: OAD
• UDI-Device Identifier: 05414734300162
• UDI-Public: 05414734300162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/22/2024

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: 05/31/2026
• Device Model Number: 402840
• Device Lot Number: 9103998
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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: SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER 8 MM
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: White