MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ TC ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP; Cardiac ablation percutaneous catheter

Model Number 402196

Device Problem Electrical Shorting (2926)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

One 7f, quadripolar, large curl, livewire tc ablation catheter was received for evaluation.Electrodes 1-2 displayed acceptable resistance values; however, a short circuit was detected between electrode 1 and conductor wire 3.Dissection revealed that the flat wire insulation was torn and the insulation for conductor wire 3 was abraded in the same location, consistent with the short circuit detected and the reported impedance and display issue.The thermistor/thermocouple met specifications during electrical testing.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.

Event Description

This report is to advise of a short circuit that was noted during analysis.

• Brand Name: LIVEWIRE¿ TC ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP
• Type of Device: 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: 17451685
• MDR Text Key: 320336609
• Report Number: 2182269-2023-00037
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P960016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402196
• Device Lot Number: 8012273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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