MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE TC ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP; CATHETER, PERCUTANEOUS CARDIAC ABLATION

Model Number 402196

Device Problem Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

One 7f, quadripolar, large curl, xls livewire tc ablation catheter was received for evaluation.The device was returned due to a signal issue on electrode 3.Visual inspection revealed a black foreign material completely covering electrode 3 and a signal was unable to be obtained from the electrode.Electrical testing revealed a short circuit between the tip electrode and electrode 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 reported signal issue.Further investigation concluded the black material found on electrode 3 to be a biological foreign material.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 noted during analysis confirming a short circuit.

• Brand Name: LIVEWIRE TC ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONITORING QUADRIP
• Type of Device: CATHETER, PERCUTANEOUS CARDIAC ABLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10372540
• MDR Text Key: 201839820
• Report Number: 2182269-2020-00069
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 402196
• Device Lot Number: 6967120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/06/2020
• Date Device Manufactured: 05/20/2019
• 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
• Patient Age: 57 YR