MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	UNK_NAVISTAR THERMOCOOL
Medical Device Problem Codes	Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Arrhythmia (1721); Chest Pain (1776); Dyspnea (1816); Fatigue (1849)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: kulakowski p, baran j, sikorska a, krynski t, niedzwiedz m, soszynska m, piotrowski r.Cardioneuroablation for reflex asystolic syncope: mid-term safety, efficacy, and patient's acceptance.Heart rhythm.2024 mar;21(3):282-291.Doi: 10.1016/j.Hrthm.2023.11.022.Epub 2023 nov 29.Pmid: 38036236.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 no lot number was 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 ref # (b)(4).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: kulakowski p, baran j, sikorska a, krynski t, niedzwiedz m, soszynska m, piotrowski r.Cardioneuroablation for reflex asystolic syncope: mid-term safety, efficacy, and patient's acceptance.Heart rhythm.2024 mar;21(3):282-291.Doi: 10.1016/j.Hrthm.2023.11.022.Epub 2023 nov 29.Pmid: 38036236.Objective/methods/study data: background: cardioneuroablation (cna) is a promising therapy for reflex asystolic syncope; however, convincing data on the mid-term safety and efficacy of this procedure are lacking.Objective: the purpose of this study was to assess the mid-term safety, efficacy, and patient acceptance of cna.Methods: this prospective observational single-center study included 115 consecutive patients (mean age 39 ± 13 years; 58% female) treated between 2016 and 2022 who completed at least 1-year follow-up.Results: no significant procedure-related acute complications occurred.During median follow-up of 28 months (range 12-75), 95 (83%) remained free from syncope.Of the 20 patients (17%) with syncope recurrence, syncope burden decreased from a mean 17 (median 6.5) to 3.75 (median 2.5) episodes (p =.015).In 9 of 10 patients, pacing system removal was possible.Repeated cna was needed in 3 patients (3%), whereas pacemaker implantation was performed in 5 (4%).The most frequent mid-term complication of cna was sinus rhythm acceleration (from 60 ± 14 bpm to 90 ± 16 bpm; p <.0001), which was symptomatic in 31 patients (27%); 8 patients (7%) required chronic beta-blocker and/or ivabradine.Sinus node modification was necessary in 1 patient.Other complaints included dyspnea, chronic chest pain, and decreased exercise capacity, which were mild and reported by 16 patients (14%).Patient acceptance of cna was very high: 96% stated that it was worth undergoing the procedure.Conclusions: mid-term efficacy of cna exceeds 80%, and acute complications are absent.The most frequent mid-term chronic complication is inappropriate sinus tachycardia, which in 7% required chronic treatment.The procedure is well accepted by patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar thermocool smarttouch catheter.Concomitant biosense webster devices that were used in this study: carto concomitant non-biosense webster devices that were also used in this study: acunav ice catheter.Adverse event(s) and provided interventions possibly associated with unidentified navistar thermocool smarttouch catheter: qty 7 ¿ inappropriate sinus tachycardia-like symptoms (arhythmia) that required long-term beta blocker and/or ivabradine treatment (recognized procedural complication) (off label use).Qty 1 inappropriate sinus tachycardia-like symptoms (arrhythmia) that required sinus node modification because of intractable sinus tachycardia that did not respond to pharmacotherapy (surgical intervention) (off label use).Qty 3 ¿ (dyspnea) (chest pain) and decreased exercise capacity (fatigue) who underwent repeated cardioneuroablation (surgical intervention) (off label use).Nonserious event(s) and provided interventions possibly associated with unidentified navistar thermocool smarttouch catheter: qty 23 ¿ symptomatic sinus rhythm increase (arrhythmia) and within 1-18 months heart rate returned to values that did not cause any symptoms (recognized procedural complication) (off label use).Qty 5 ¿ (dyspnea) (chest pain) and decreased exercise capacity (fatigue) (recognized procedural complication) (off label use).

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 19625850
• Report Number: 2029046-2024-02121
• Device Sequence Number: 12792456
• Product Code: OAD
• UDI-Device Identifier: 10846835008357
• UDI-Public: 10846835008357
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACUNAV ICE CATHETER; CARTO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown