MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	402811
Medical Device Problem Codes	Signal Artifact/Noise (1036); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing reference: 2182269-2023-00016.During a paroxysmal supraventricular tachycardia (psvt) procedure, the generator showed the catheter temperature as high.The cable was exchanged with no resolution.The catheter was exchanged but the high temperature issue was not resolved and noise was also noted.The catheter was exchanged to a third one and the procedure was completed with no adverse consequence to the patient.
Additional Manufacturer Narrative
One 4mm tip, large curl, safire ablation catheter was received for evaluation.The catheter successfully attached to a test box with no anomalies noted.Electrodes 1-4 displayed acceptable resistance values ranging from 1.3 ohms to 1.9 ohms while the device was undeflected, deflected, and manipulated, with no open or short circuits detected.The resistance value between pins 11 and 12 read as 152.2 ohms and the value between 12 and 13 read as 24.3 ohms while undeflected, deflected, and during manipulation, which met specifications.The temperature response was checked at three settings: 25.0°c, 37.0°c and 90.0°c using a calibrated system.The catheter displayed the following temperature readings: 25.3°c, 36.9°c, and 93.0°c.The temperature response of the thermocouple was within specification.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported issue remains unknown.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16591508
• Report Number: 2182269-2023-00017
• Device Sequence Number: 2907040
• Product Code: LPB
• UDI-Device Identifier: 05414734206020
• UDI-Public: 05414734206020
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P960016-S014
• 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): 04/17/2023

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: 07/31/2025
• Device Model Number: 402811
• Device Catalogue Number: 402811
• Device Lot Number: 8619731
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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¿ BI-DIRECTIONAL ABLATION CATHETER
• Patient Sex: Unknown