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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 01/28/2024

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: shimizu y, yoshitani k, kuriyama t, mori k, kujira k, imai m, fukuhara r, taniguchi r, toma m, miyamoto t, sato y.The effect of an initial catheter ablation with an adjunctive ethanol infusion into the vein of marshall on persistent atrial fibrillation.J cardiovasc electrophysiol.2024 mar;35(3):453-460.Doi: 10.1111/jce.16191.Epub 2024 jan 28.Pmid: 38282242.Objective/methods/study data: introduction: some previous studies have reported that a first-step ethanol infusion into the vein of marshall (eivom) with touch-up radiofrequency (rf) ablation can facilitate mitral isthmus (mi) block and improves the ablation outcomes in persistent atrial fibrillation (peaf) patients.However, the effect of an initial rf ablation with an adjunctive eivom has not been fully investigated.Methods: this study enrolled 233 peaf patients undergoing pulmonary vein isolation and linear ablation including an mi, roof line, and cavotricuspid isthmus ablation.An eivom was performed when endocardial ablation with or without coronary sinus ablation failed to create mi block.Results: bidirectional mi block was achieved in 224 patients (96.1%).Among them, mi block was obtained by only rf ablation in 174/224 patients (77.7%) (rf group) and an adjunctive eivom was needed in 50/224 (22.3%) (eivom group).During the follow-up, 113 (64.9%) rf group patients were free from af/atrial tachycardia compared to 41 (82.0%) eivom group patients (log-rank p =.045).In a multivariate cox regression analysis, an adjunctive eivom was associated with a lower recurrence rate (hazard ratio = 0.39, 95% confidence interval = 0.17-0.78, p =.006).Conclusion: an initial rf ablation with an adjunctive eivom strategy improved mi ablation's acute success rate and was associated with better clinical outcomes.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf ablation catheter - for mi ablation concomitant biosense webster devices that were used in this study: carto3 mapping system concomitant non-biosense webster devices that were also used in this study: selectra right cs guiding catheter (biotronik), inquiry luma-cath electrode catheter (st.Jude), bard ep recording system (boston scientific), intellatip ablation catheter (boston scientific), emerge over-the-wire balloon (boston scientific), orion mapping catheter (boston scientific).The intellatip was used for cti ablation.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch sf ablation catheter for mi ablation: qty 1 (cardiac tamponade) that required pericardiocentesis (recognized procedural complication).Qty 1 symptoms that last 2 days after procedure of (pericarditis) treated with acetaminophen (recognized procedural complication).

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: shimizu y, yoshitani k, kuriyama t, mori k, kujira k, imai m, fukuhara r, taniguchi r, toma m, miyamoto t, sato y.The effect of an initial catheter ablation with an adjunctive ethanol infusion into the vein of marshall on persistent atrial fibrillation.J cardiovasc electrophysiol.2024 mar;35(3):453-460.Doi: 10.1111/jce.16191.Epub 2024 jan 28.Pmid: 38282242.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® 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: 18924120
• MDR Text Key: 337905234
• Report Number: 2029046-2024-00883
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BARD EP RECORDING SYSTEM (BOSTON SCIENTIFIC).; CARTO3 MAPPING SYSTEM,; EMERGE OVER-THE-WIRE BALLOON (BOSTON SCIENTIFIC.; INQUIRY LUMA-CATH ELECTRODE CATHETER (ST. JUDE).; INTELLATIP ABLATION CATHETER (BOSTON SCIENTIFIC).; ORION MAPPING CATHETER (BOSTON SCIENTIFIC).; SELECTRA RIGHT CS GUIDING CATHETER (BIOTRONIK).
• Patient Outcome(s): Life Threatening