MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ TC ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP; Cardiac ablation percutaneous catheter

Model Number	402152
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a short circuit that was noted during analysis.
Additional Manufacturer Narrative
One 7f, quadripolar, large curl, xls livewire tc ablation catheter was received for evaluation.A short circuit was detected between electrode 1 and conductor wire 2.Dissection revealed that the flat wire insulation was torn and the insulation for conductor wire 2 was abraded in the same location, consistent with the short circuit detected and the reported signal issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn insulation and abraded wires remains unknown.

• Brand Name: LIVEWIRE¿ TC ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP
• 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: 18115040
• Report Number: 2182269-2023-00050
• Device Sequence Number: 17896569
• Product Code: LPB
• UDI-Device Identifier: 05414734200257
• UDI-Public: 05414734200257
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P960016
• 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
• Report Date (Section B): 11/10/2023

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: 06/30/2025
• Device Model Number: 402152
• Device Lot Number: 8356554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• 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: 11/03/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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
• Patient Sex: Unknown