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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: han y, shao m, yang h, sun h, sang w, wang l, wang l, yang s, jian y, tang b, li y.Safety and efficacy of cardioneuroablation for vagal bradycardia in a single arm prospective study.Sci rep.2024 mar 11;14(1):5926.Doi: 10.1038/s41598-024-56651-9.Pmid: 38467744; pmcid: pmc10928196.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: han y, shao m, yang h, sun h, sang w, wang l, wang l, yang s, jian y, tang b, li y.Safety and efficacy of cardioneuroablation for vagal bradycardia in a single arm prospective study.Sci rep.2024 mar 11;14(1):5926.Doi: 10.1038/s41598-024-56651-9.Pmid: 38467744; pmcid: pmc10928196.Objective/methods/study data: cardioneuroablation (cna) is currently considered as a promising treatment option for patients with symptomatic bradycardia caused by vagotonia.This study aims to further investigate its safety and efficacy in patients suffering from vagal bradycardia.A total of 60 patients with vagal bradycardia who underwent cna in the first affiliated hospital of xinjiang medical university from november 2019 to june 2022.Preoperative atropine tests revealed abnormal vagal tone elevation in all patients.First, the electroanatomic structures of the left atrium was mapped out by using the carto 3 system, according to the protocol of purely anatomy-guided and local fractionated intracardiac electrogram-guided cna methods.The upper limit of ablation power of superior left ganglion (slgp) and right anterior ganglion (ragp) was not more than 45w with an ablation index of 450.Postoperative transesophageal cardiac electrophysiological examination was performed 1 to 3 months after surgery.The atropine test was conducted when appropriate.Twelve-lead electrocardiogram, holter electrocardiogram, and skin sympathetic nerve activity were reviewed at 1, 3, 6 and 12 months after operation.Adverse events such as pacemaker implantation and other complications were also recorded to analyze the safety and efficacy of cna in the treatment of vagus bradycardia.Sixty patients were enrolled in the study (38 males, mean age 36.67 ± 9.44, ranging from 18 to 50 years old).None of the patients had a vascular injury, thromboembolism, pericardial effusion, or other surgical complications.The mean heart rate, minimum heart rate, low frequency, low/high frequency, acceleration capacity of rate, and skin sympathetic nerve activity increased significantly after cna.Conversely, sdnn, pnn50, rmssd, high frequency, and deceleration capacity of rate values decreased after cna (all p < 0.05).At 3 months after ablation, the average heart rate, maximum heart rate, and acceleration capacity of heart rate remained higher than those before ablation, and the deceleration capacity of heart rate remained lower than those before ablation and the above results continued to follow up for 12 months after ablation (all p < 0.05).There was no significant difference in other indicators compared with those before ablation (all p > 0.05).The remaining 81.67% (49/60) of the patients had good clinical results, with no episodes of arrhythmia during follow-up.Cna may be a safe and effective treatment for vagal-induced bradycardia, subject to confirmation by larger multicenter trials.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar 4-mm ablation catheter concomitant biosense webster devices that were used in this study: carto 3 system concomitant non-biosense webster devices that were also used in this study: e ge healthcare stimulation instrument (ge healthcare) adverse event(s) and provided interventions possibly associated with unidentified navistar 4-mm ablation catheter: qty 2: two patients were implanted permanent pacemakers after cna was proved ineffective by atropine test.(surgical intervention) (av heart block) (adverse event).

• 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: 19618083
• Report Number: 2029046-2024-02097
• Device Sequence Number: 20409658
• Product Code: OAD
• UDI-Device Identifier: 10846835008357
• UDI-Public: 10846835008357
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 05/28/2024
• Initial Report FDA Received Date: 06/26/2024
• 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: GE HEALTHCARE STIMULATION INSTRUMENT; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown