MAUDE Adverse Event Report: ST. JUDE MEDICAL LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL; CATHETER, STEERABLE

Model Number 401908

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 09/16/2021

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

During a ventricular tachycardia (vt) ablation procedure, a pericardial effusion and subsequent pericardial tamponade occurred and the patient passed away.While mapping with the advisor hd grid and the livewire catheters, the patient experienced a large effusion around the right ventricle which turned into a cardiac tamponade.A pericardial window was performed, but the patient went into pulseless electrical activity.Chest compressions were performed but the patient was unable to be revived and the patient passed away.There were no performance issues with any abbott devices.The physician alleged the perforation was caused by the livewire catheter.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), MEDIUM CURL
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12533258
• MDR Text Key: 273354241
• Report Number: 2182269-2021-00074
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202558
• UDI-Public: 05414734202558
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 401908
• Device Catalogue Number: 401908
• Device Lot Number: 7762591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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 Outcome(s): Death
• Patient Weight: 124