MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	UNK_SMART TOUCH BIDIRECTIONAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Insufficient Information (4580)
Date of Event	05/02/2024
Type of Reportable Event	Death
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: ¿i¿ek d, mrak m, jan m, zupan me¿nar a, ivanovski m, ¿lahtic t, kajdic n, antolic b, klemen l, skale r, avramovic gregoric j, ¿tublar j, pernat a, ¿inkovec m.Impact of preventive substrate catheter ablation on implantable cardioverter-defibrillator interventions in patients with ischaemic cardiomyopathy and infarct-related coronary chronic total occlusion.Europace.2024 may 2;26(5):euae109.Doi: 10.1093/europace/euae109.(b)(6).Objective/methods/study data: aims primary prevention patients with ischaemic cardiomyopathy and chronic total occlusion of an infarct-related coronary artery (cto) are at a particularly high risk of implantable cardioverter-defibrillator (icd) therapy occurrence.The trial was designed to evaluate the efficacy of preventive cto-related substrate ablation strategy in ischaemic cardiomyopathy patients undergoing primary prevention icd implantation.Methods and results the preventive vt study was a prospective, multicentre, randomized trial including ischaemic patients with ejection fraction =40%, no documented ventricular arrhythmias (vas), and evidence of scar related to the coronary cto.Patients were randomly assigned 1:1 to a preventive substrate ablation before icd implantation or standard therapy with icd implantation only.The primary outcome was a composite of appropriate icd therapy or unplanned hospitalization for vas.Secondary outcomes included the primary outcome¿s components, the incidence of appropriate icd therapies, cardiac hospitalization, electrical storm, and cardiovascular (cv) mortality.Sixty patients were included in the study.During the mean follow-up of 44.7 ± 20.7 months, the primary outcome occurred in 5 (16.7%) patients undergoing preventive substrate ablation and in 13 (43.3%) patients receiving only icd [hazard ratio (hr): 0.33; 95% confidence interval (ci): 0.12¿0.94; p = 0.037].Patients in the preventive ablation group also had fewer appropriate icd therapies (p = 0.039) and the electrical storms (log-rank: p = 0.01).While preventive ablation also reduced cardiac hospitalizations (p = 0.006), it had no significant impact on cv mortality (p = 0.151).Conclusion preventive ablation of the coronary cto-related substrate in patients undergoing primary icd implantation is associated with the reduced risk of appropriate icd therapy or unplanned hospitalization due to vas.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch® concomitant biosense webster devices that were used in this study: carto 3 system, pentaray, smartttouch sf concomitant non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions possibly associated with unidentified unknown smarttouch®: qty 1: one patient underwent crt implantation (surgical intervention) due to the iatrogenic complete atrioventricular block (av heart block) (adverse event) qty 1: one patient suffered a post-procedural ischaemic stroke (cerebrovascular accident) which resolved without consequences.(recognized procedural complication) (adverse event) qty 8: cardiovascular deaths (death) (no information available) (adverse event - death) qty 4: deaths (death) were attributed to arrhythmic causes (arrhythmia) (adverse event - death) qty 14: heart failure hospitalization (prolonged surgery) (heart failure) (adverse event) qty 20: unplanned cardiac hospital admission (prolonged hospitalization) (no information available) (adverse event) qty 6: electrical storm (arrhythmia) (recognized procedural complication) (adverse event).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: ¿i¿ek d, mrak m, jan m, zupan me¿nar a, ivanovski m, ¿lahtic t, kajdic n, antolic b, klemen l, skale r, avramovic gregoric j, ¿tublar j, pernat a, ¿inkovec m.Impact of preventive substrate catheter ablation on implantable cardioverter-defibrillator interventions in patients with ischaemic cardiomyopathy and infarct-related coronary chronic total occlusion.Europace.2024 may 2;26(5):euae109.Doi: 10.1093/europace/euae109.Pmid: 38657209; pmcid: pmc11086562.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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: 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: 19600296
• Report Number: 2029046-2024-02054
• Device Sequence Number: 8204566
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: P030031/S053
• 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): 06/24/2024

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_SMART TOUCH BIDIRECTIONAL
• 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: 05/27/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CARTO 3 SYSTEM; PENTARAY; SMARTTTOUCH SF
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown