MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE

Model Number 401582

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/22/2019

Event Type  Injury  

Event Description

Manufacturing related ref: 3008452825-2019-00572, 3005334138-2019-00622.During the ventricular tachycardia ablation procedure near the left apex of the left ventricular, a pericardial effusion occurred.At the end of the procedure, the patient became hypotensive, and bradycardia was exhibited.Pacing was performed and the blood pressure was 80/60.After three minutes, the patient became hypotensive again so an echocardiography was performed showing a pericardial effusion requiring a pericardiocentesis.The patient was transferred to the ccu unit and will be monitored.

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 pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

The patient was discharged the following day.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9310761
• MDR Text Key: 166774660
• Report Number: 2182269-2019-00239
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202251
• UDI-Public: 05414734202251
• Combination Product (y/n): N
• PMA/PMN Number: K913940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 401582
• Device Catalogue Number: 401582
• Device Lot Number: 6989575
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD 16 ELECTRODE DF BI-D OUS; TACTICATH SE CATHETER, UNI-D, CURVE F
• Patient Outcome(s): Other; Required Intervention