MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446); Pericarditis (4448)

Event Type  Injury  

Manufacturer Narrative

An article was received entitled "50w vs 40w during high-power short-duration ablation for paroxysmal atrial fibrillation" this complaint is from a literature source.The following literature cite has been reviewed: costea a, diaz jc, osorio j, matos cd, hoyos c, goyal s, te c, d'souza b, rastogi m, lopez-cabanillas n, ibanez lc, thorne c, varley al, zei pc, sauer wh, romero je.50w vs 40w during high-power short-duration ablation for paroxysmal atrial fibrillation: a multicenter prospective study.Jacc clin electrophysiol.2023 sep 5:s2405-500x(23)00618-7.Doi: 10.1016/j.Jacep.2023.08.005.Epub ahead of print.Pmid: 37804258.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was not provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

An article was received entitled "50w vs 40w during high-power short-duration ablation for paroxysmal atrial fibrillation" this complaint is from a literature source.The following literature cite has been reviewed: costea a, diaz jc, osorio j, matos cd, hoyos c, goyal s, te c, d'souza b, rastogi m, lopez-cabanillas n, ibanez lc, thorne c, varley al, zei pc, sauer wh, romero je.50w vs 40w during high-power short-duration ablation for paroxysmal atrial fibrillation: a multicenter prospective study.Jacc clin electrophysiol.2023 sep 5:s2405-500x(23)00618-7.Doi: 10.1016/j.Jacep.2023.08.005.Epub ahead of print.Pmid: 37804258.Objective/methods/study data: background high-power short-duration (hpsd) radiofrequency ablation of atrial fibrillation (af) increases first-pass pulmonary vein isolation (pvi) and freedom from atrial arrhythmias while decreasing procedural time.However, the optimal power setting in terms of safety and efficacy has not been determined.Objectives this study compared the procedural characteristics and clinical outcomes of 50w vs 40w during hpsd ablation of paroxysmal af.Methods patients from the real-af prospective multicenter registry (real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation) undergoing hpsd ablation of paroxysmal af, either using 50w or 40w, were included.The primary efficacy outcome was freedom from all-atrial arrhythmias.The primary safety outcome was the occurrence of any procedural complication at 12 months.Secondary outcomes included procedural characteristics, af-related symptoms, and the occurrence of transient ischemic attack or stroke at 12 months.Results a total of 383 patients were included.Freedom from all-atrial arrhythmias at 12 months was 80.7% in the 50w group and 77.3% in the 40w group (log-rank p ¼ 0.387).The primary safety outcome occurred in 3.7% of patients in the 50w group vs 2.8% in the 40w group (p ¼ 0.646).The 50w group had a higher rate of first-pass pvi (82.3% vs 76.2%; p ¼ 0.040) as well as shorter procedural (67 minutes [iqr: 54-87.5 minutes] vs 93 minutes [iqr: 80.5-111 minutes]; p < 0.001) and radiofrequency ablation times (15 minutes [iqr: 11.4-20 minutes] vs 27 minutes [iqr: 21.5-34.6 minutes]; p < 0.001) than the 40w group.Conclusions there was no significant difference in freedom from all-atrial arrhythmias or procedural safety outcomes between 50w and 40w during hpsd ablation of paroxysmal af.The use of 50w was associated with a higher rate of first-pass pvi as well as shorter procedural times.(j am coll cardiol ep 2023;-:-¿-) © 2023 by the american college of cardiology foundation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch surround flow.Other biosense webster devices that were also used in this study: carto 3 non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: 1 pericardial effusion with unknown intervention, 1 heart failure exacerbation with unknown intervention, 1 pericarditis with unknown intervention.

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18211843
• MDR Text Key: 329064637
• Report Number: 2029046-2023-02754
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009231
• UDI-Public: 10846835009231
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• 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: CARTO 3
• Patient Outcome(s): Life Threatening