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 Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned due to a signal issue.Electrodes 1-4 displayed acceptable resistance values; however, a short circuit was detected between electrode 1 and conductor wire 4.Dissection revealed that the flat wire insulation was torn and the insulation for conductor wire 4 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 or Problem Description
This report is to advise of an event observed during analysis, confirming a short circuit identified within the device.

• 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
• MDR Report Key: 10908821
• Report Number: 2182269-2020-00113
• Device Sequence Number: 3084125
• Product Code: LPB
• UDI-Device Identifier: 05414734200257
• UDI-Public: 05414734200257
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 402152
• Device Catalogue Number: 402152
• Device Lot Number: 7420769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1