MAUDE Adverse Event Report: ST. JUDE MEDICAL LIVEWIRE TC ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP; CATHETER, PERCUTANEOUS CARDIAC ABLATION

Model Number 402114

Device Problem Failure to Analyze Signal (1539)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

One 7f, quadripolar, medium curl, xls livewire tc ablation catheter was received for evaluation.Electrodes 1-4 displayed acceptable resistance values; however, 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 short circuit is consistent with damage during use.

Event Description

This report is to advise of an event observed during analysis confirming a short circuit.

• Brand Name: LIVEWIRE TC ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP
• Type of Device: CATHETER, PERCUTANEOUS CARDIAC ABLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12245021
• MDR Text Key: 266163023
• Report Number: 2182269-2021-00065
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 402114
• Device Lot Number: 7180490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1