MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Perforation (2513); Pericarditis (4448)

Event Date 07/20/2023

Event Type  Injury  

Event Description

An article was received entitled "acute and mid-term outcomes of ablation for atrial fibrillation with visitag surpoint: the japan miyabi registry".This complaint is from a literature source.The following literature cite has been reviewed: okumura k, inoue k, goya m, origasa h, yamazaki m, nogami a.Acute and mid-term outcomes of ablation for atrial fibrillation with visitag surpoint: the japan miyabi registry.Europace.2023 aug 2;25(9):euad221.Doi: 10.1093/europace/euad221.Pmid: 37490850; pmcid: pmc10492225.Objective/methods/study data: aims the effectiveness of pulmonary vein isolation (pvi) guided by visitag surpoint (vs) has been demonstrated in western populations.However, data for asian populations are limited.Vs settings may differ for asians, given their smaller body size.This study aimed to describe outcomes of radiofrequency atrial fibrillation (af) ablation guided by vs in a large asian population.Methods and results: the prospective, observational, multicentre miyabi registry collected real-world data from patients undergoing vs-guided af ablation using thermocool smarttouch and thermocool smarttouch sf catheters from 50 japanese centres.All patients had paroxysmal af or persistent af for <6 months.Primary adverse events (paes) were evaluated for safety.The primary efficacy endpoint was the proportion of patients with pvi at the end of the procedure.Mid-term effectiveness (up to 12 months) was evaluated by freedom from documented atrial arrhythmias.Of the 1011 patients enrolled, 1002 completed af ablation.The mean number of vs values per procedure was 428.8 on the anterior wall and 400.4 on the posterior wall.Nine patients (0.9%) experienced paes.Upon procedure completion, 99.7% of patients had pvi.Twelve-month freedom from atrial arrhythmia recurrence was 88.5%; 5.7% of patients were re-ablated.At repeat ablation, 54% of rspv, 73% of ripv, 70% of lspv, and 86% of lipv evaluated remained durably isolated.Conclusion despite lower anterior wall vs values compared with the close protocol (=550), the present study demonstrated comparable efficacy outcomes, indicating that a vs of =550 for the anterior wall may not be necessary for asian patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf other biosense webster devices that were also used in this study: carto 3 visitag module non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: qty 3 cardiac temponade/perforation, qty 2 pericarditis.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: okumura k, inoue k, goya m, origasa h, yamazaki m, nogami a.Acute and mid-term outcomes of ablation for atrial fibrillation with visitag surpoint: the japan miyabi registry.Europace.2023 aug 2;25(9):euad221.Doi: 10.1093/europace/euad221.Pmid: 37490850; pmcid: (b)(4).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.D4.Catalog should be unk_smart touch bidirectional sf.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.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: 17928042
• MDR Text Key: 325564086
• Report Number: 2029046-2023-02314
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• 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: 09/20/2023
• 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: UNK_CARTO 3; UNK_VISITAG SURPOINT¿ EPU
• Patient Outcome(s): Life Threatening