MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),; CATHETER, STEERABLE

Model Number 401932

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

An event of a pericardial effusion was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Additionally, the device history record (dhr) was unable to be reviewed.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of the device.

Event Description

Related manufacturing ref: 3005334138-2019-00600, 3005334138-2019-00601.During an atrial fibrillation procedure, a pericardial effusion occurred.When isolating the pulmonary veins, the impedance readings were high around 160 ohms.A second grounding pad was placed on the patient and the impedance decreased to 95 - 110 ohms.15 ablations were carried out near the antrum of left superior pulmonary vein, posterior wall and roof when an impedance limit cutoff error message was observed and noise was observed on the distal electrode on the mapping and recording systems.The catheter was replaced.While prepping the second catheter, the patient became hypotensive.Intracardiac ultrasound revealed a small pericardial effusion.The patient stabilized and no intervention was needed for the effusion.The procedure was discontinued.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),
• Type of Device: CATHETER, STEERABLE
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9295400
• MDR Text Key: 165570263
• Report Number: 2182269-2019-00194
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913940
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401932
• Device Catalogue Number: 401932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ADVISOR¿ HD GRID MAPPING CATHETER; TACTICATH¿ CONTACT FORCE CATHETER
• Patient Outcome(s): Other