MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number SEE H10.

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Transient Ischemic Attack (2109); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: schade a, costello-boerrigter l, deneke t, steinborn f, chapran m, vathie k, milisavljevic n, franz m, surber r, assani m, hamo h, khshfeh m, lauten a, mattea v.Oesophageal safety in voltage-guided atrial fibrillation ablation using ablation index or contact force only: a prospective comparison.Europace.2022 dec 9;24(12):1909-1916.Doi: 10.1093/europace/euac103.Pmid: 35851917.Note: catalog number should be: unk_smart touch bidirectional sf.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no 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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: schade a, costello-boerrigter l, deneke t, steinborn f, chapran m, vathie k, milisavljevic n, franz m, surber r, assani m, hamo h, khshfeh m, lauten a, mattea v.Oesophageal safety in voltage-guided atrial fibrillation ablation using ablation index or contact force only: a prospective comparison.Europace.2022 dec 9;24(12):1909-1916.Doi: 10.1093/europace/euac103.Pmid: 35851917.Abstract:aims: left atrial ablation using radiofrequency (rf) is associated with endoscopically detected thermal oesophageal lesions (edels).The aim of this study was to compare edel occurrence after conventional contact force-guided (cfg) rf ablation vs.An ablation index-guided (aig) approach in clinical routine of voltage-guided ablation (vga).Predictors of edel were also assessed.Methods and results: this study compared cfg (n = 100) with aig (n = 100) in consecutive atrial fibrillation ablation procedures, in which both pulmonary vein isolation and vga were performed.In the aig group, ai targets were =500 anteriorly and =350-400 posteriorly.Upper endoscopy was performed after ablation.The cfg and aig groups had comparable baseline characteristics.The edel occurred in 6 and 5% (p = 0.86) in the cfg and aig groups, respectively.Category 2 lesions occurred in 4 and 2% (p = 0.68), respectively.All edel healed under proton pump inhibitor therapy.The ai > 520 was the only predictor of edel [odds ratio (or) 3.84; p = 0.039].The more extensive category 2 lesions were predicted by: ai max > 520 during posterior ablation (or 7.05; p = 0.042), application of posterior or roof lines (or 5.19; p = 0.039), existence of cardiomyopathy (or 4.93; p = 0.047), and cha2ds2-vasc score (or 1.71; p = 0.044).The only category 2 lesion with ai max < 520 (467) occurred in a patient with low body mass index.Conclusions: both methods were comparable with respect to clinical complications and edel.In consideration of previous reconnection data and our study results regarding oesophageal safety, optimal ai target range might be between 400 and 450.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: thermocool smarttouch sf.Other biosense webster devices that were also used in this study: carto 3 visitag (visitag¿ parameters were tag size of 3 mm, location stability of 2.5, minimum time of 3 s, force over time of 25%, minimum force of 3 g.Visitag colouring varied continuously between 0 and 30 s.Respiratory gating was used for visitag application), lasso mapping catheter.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: qty 3 transient ischemic attacks (intervention not discussed), qty 3 pseudoaneurysms requiring surgical intervention, qty 1 pericardial effusion (intervention not discussed), and qty 1 sinus arrest requiring pacemaker implantation.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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: 16483271
• MDR Text Key: 310684632
• Report Number: 2029046-2023-00472
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• 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 VISITAG; LASSO MAPPING CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening