MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ TC ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

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

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

The following was published in herzschrittmachertherapie & elektrophysiologie (nov 10, 2023) "zero-fluoro atrioventricular-nodal reentrant tachycardia ablation"; soether, christina the authors retrospectively analyzed 68 patients that underwent avnrt-rfca.One group was a priori allocated to conventional fluoroscopy mapping.In 38 cases, the electrophysiologist chose to use 3d-eam for ablation.Of these patients, 20 could be ablated without fluoroscopy use (zerofluoro).In 18 cases that were initially intended as 3d-eam, additional fluoroscopy use was necessary due to difficult anatomic conditions (convertedfluoro).Procedure duration, fluoroscopy duration and dose, as well as complications were analyzed.Procedure duration was similar for the convfluoro and zerofluoro groups.The convertedfluoro group showed longer procedure duration compared to the convfluoro group.The use of 3d-eam significantly reduced fluoroscopy duration comparing the convfluoro with the convertedfluoro group.The difference in fluoroscopy dose between convfluoro and converted fluoro did not reach significance.In zerofluoro cases, no radiation was used at all.3d-eam-guided rfca was primarily successful in all patients.Overall, there were only few minor complications in the different groups.No major complications occurred.One transient right bundle branch block (rbbb), four transient atrioventricular (av) block iii and one av block ii occurred with full recovery each.No major (persistent) complications occurred in any group.

Manufacturer Narrative

Additional information: d9, g1, g3, h2, h3, h6 the results of the investigation are inconclusive since the device was 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 incident could not be conclusively determined.

• Brand Name: LIVEWIRE¿ TC ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18248184
• MDR Text Key: 329501471
• Report Number: 2182269-2023-00055
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening