MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER; ELECTRODE RECORDING CATHETER

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Inflammation (1932); Great Vessel Perforation (2152); Cardiac Perforation (2513); Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: tacticath catheter, reflexion spiral catheter, event date unknown.The results of the investigation are inconclusive since the devices were not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incidents could not be conclusively determined.

Event Description

Related manufacturer reference number: (b)(4).The following was published in heart rhythm society in an article titled ¿high power short duration atrial fibrillation ablations using contact force sensing catheters: outcomes and predictors of success including posterior wall isolation¿ by winkle r, hardwin mean r, engel g, et.Al., 23 march 2020.¿atrial fibrillation (af) ablation has become a standard treatment for patients with af.Ablation therapy reduces af burden and alleviates symptoms.Little is known about the long-term outcomes and predictors of success for high power short duration (hpsd) contact force (cf) atrial fibrillation ablations.The objective is to determine long-term freedom from af and predictors of freedom from af for 50w 5-15 second cf ablation.During the study they examined 4-year (march 27, 2014-december 31, 2017) outcomes and predictors of freedom from af for 1250 consecutive patients undergoing hpsd cf ablation.Minor complications included significant pericarditis in 3 patients, tias in less than 48 hours in 2, and a skin tear from an electrode in 1.Major complications included a retroperitoneal or radial arterial bleed requiring surgical or catheter-based intervention in 6, pericardial tamponade requiring pericardiocentesis in 3, aortic perforation requiring no treatment in 1, 2 strokes occurring immediately after the procedure.One of the strokes, in an elderly female, was enlarged during efforts to retrieve a clot and the patient died 7 days later.The other stroke gradually resolved.¿ (https://doi.Org/10.1016/j.Hrthm.2020.03.022).

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• 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: 9983409
• MDR Text Key: 191834449
• Report Number: 2182269-2020-00034
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/21/2020
• 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
• Patient Outcome(s): Required Intervention