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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: long s, sun y, xiao x, wang z, sun w, gao l, xia y, yin x.Benefit of catheter ablation for atrial fibrillation in heart failure patients with different etiologies.J cardiovasc dev dis.2023 oct 20;10(10):437.Doi: 10.3390/jcdd10100437.Pmid: 37887884; pmcid: pmc10607920.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 the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: long s, sun y, xiao x, wang z, sun w, gao l, xia y, yin x.Benefit of catheter ablation for atrial fibrillation in heart failure patients with different etiologies.J cardiovasc dev dis.2023 oct 20;10(10):437.Doi: 10.3390/jcdd10100437.Pmid: 37887884; pmcid: pmc10607920.Objective/methods/study data: abstract (1) background: a plethora of studies have elucidated the safety and efficacy of catheter ablation (ca) for patients afflicted with atrial fibrillation (af) and concomitant reduction in left ventricular ejection fraction (lvef).Nevertheless, the literature on the benefits of ca in the specific etiological context of heart failure (hf) remains limited.This study delineates a comparative assessment of outcomes for patients with af and reduced lvef across the primary etiologies.(2) methods: our inquiry encompassed 216 patients diagnosed with congestive heart failure and an lvef of less than 50 percent who were referred to our institution for circumferential pulmonary vein isolation (cpvi) between the years 2016 and 2020.The selection criteria included a detailed medical history while excluding those suffering from valvular disease, congenital heart disease, and hypertrophic cardiomyopathy.In an effort to scrutinize varying etiologies, patients were stratified into three categories: dilated cardiomyopathy (dcm, n = 56, 30.6%), ischemic cardiomyopathy (icm, n = 68, 37.2%), and tachycardia-induced cardiomyopathy (tic, n = 59, 32.2%).(3) results: following an average (±sd) duration of 36 ± 3 months, the prevalence of sinus rhythm was 52.1% in the dcm group, 50.0% in the icm group, and 68.14% in the tic group (p = 0.014).This study revealed a significant disparity between the dcm and tic groups (p = 0.021) and the icm and tic groups (p = 0.007), yet no significant distinction was discerned between the tic and icm groups (p = 0.769).Importantly, there were no significant variations in the application of antiarrhythmic drugs or recurrence of procedures among the three groups.The mortality rates were 14.29% for the dcm group and 14.71% for the icm group, which were higher than the 3.39% observed in the tic group (dcm vs.Tic p = 0.035 (hr = 4.50 (95%ci 1.38-14.67)), icm vs.Tic p = 0.021 (hr = 5.00 (95%ci 1.61-15.50))).A noteworthy enhancement in heart function was evidenced in the tic group in comparison to the dcm and icm groups, including a higher lvef (p < 0.001), diminution of lv end-diastolic diameter (p < 0.001), and an enhanced new york heart association classification (p = 0.005).Hospitalization rates for heart failure were discernibly lower in tic patients (0.98 (0,2) times) relative to those with dcm (1.74 (0,3) times, p < 0.01) and tic (1.78 (0,4) times, p < 0.001).Patients with paroxysmal atrial fibrillation and brief episodes were found to achieve superior clinical outcomes through a catheter ablation strategy.(4) conclusion: patients diagnosed with tic demonstrated a more pronounced benefit from catheter ablation compared to those with dcm and icm.This encompassed an augmented improvement in cardiac function, an enhanced maintenance of sinus rhythm, and a reduced mortality rate.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch ablation catheter.Concomitant biosense webster devices that were used in this study: webster cs catheter, pentaray mapping catheter, lasso mapping catheter, carto mapping system concomitant non-biosense webster devices that were also used in this study: sl1 transseptal sheath & needle (synaptic medical), adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 8 total (cardiac tamponade)(recognized procedural complication).

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• 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: 18934250
• MDR Text Key: 338033999
• Report Number: 2029046-2024-00909
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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: 03/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/19/2024
• 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 MAPPING SYSTEM; LASSO MAPPING CATHETER; NEEDLE (SYNAPTIC MEDICAL); PENTARAY MAPPING CATHETER; SL1 TRANSSEPTAL SHEATH; WEBSTER CS CATHETER
• Patient Outcome(s): Life Threatening