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

Catalog Number UNK_SMART TOUCH BIDIRECT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Pericarditis (4448)

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: o'neill l, almorad a, el haddad m, wielandts jy, gillis k, hilfiker g, de becker b, lycke m, tavernier r, le polain de waroux jb, duytschaever m, knecht s.Impact of catheter ablation on arrhythmia burden in patients with shock-resistant persistent atrial fibrillation.Jacc clin electrophysiol.2023 jul 18:s2405-500x(23)00390-0.Doi: 10.1016/j.Jacep.2023.06.004.Epub ahead of print.Pmid: 37542487.Objective/methods/study data:background persistent shock-resistant atrial fibrillation (af) is a challenging entity, with modest results from catheter ablation according to conventional survival analysis.Objectives the aim of this study was to determine the effect of catheter ablation on atrial tachyarrhythmia (ata) burden in persistent af patients undergoing first-time ablation with the use of an implantable cardiac monitor (icm).Methods patients with drug-resistant ongoing persistent af and at least 1 previous failed cardioversion were implanted with an icm 2 months before the procedure.All patients underwent pulmonary vein isolation with or without additional substrate ablation depending on the presence of self-terminating af on icm and left atrium size.Median af burden before and after ablation, off antiarrhythmic medication, was determined from icm recordings after review by 2 independent investigators.Results sixty patients were recruited (mean age 66 +- 9 years, 70% male).Mean left atrial diameter was 48 +- 6 mm and median cha2ds2vasc score was 2.Ten patients (17%) unexpectedly demonstrated self-terminating af before ablation.The median burden of ata before ablation was 100% (95% ci: 19.6%-100%), decreasing to 0% (95% ci: 0%-95.8%) after ablation during the post-blanking follow-up period (median reduction 100%; 95% ci: 4%-100%; p < 0.001).Twenty-seven patients (45%) experienced recurrent ata during 12-month follow-up.In these patients, median burden before ablation was 100% (95% ci: 26.9%-100%), decreasing to 11.4% (95% ci: 0.35%-99.7%) after ablation (p < 0.001).Quality of life improved significantly from baseline, driven by lack of recurrence.Conclusions patient-tailored catheter ablation results in a significant reduction in ata burden (off antiarrhythmic medication) in shock-resistant persistent af patients using icms implanted 2-months pre-procedure.These data suggest that conventional arrhythmia-free survival analysis does not capture the true impact of catheter ablation in this challenging cohort.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch 8-f irrigated contact force sensing rf ablation catheter.Other biosense webster devices that were also used in this study: lasso mapping catheter, carto 3 mapping system non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unidentified smarttouch ablation catheter: qty 1 decompensated heart failure (cardiac failure) 5 days after procedure requiring hospitalization (prolonged hospitalization) without obvious trigger qty 2 (pericarditis) without pericardial effusion managed conservatively (minor injury).

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: o'neill l, almorad a, el haddad m, wielandts jy, gillis k, hilfiker g, de becker b, lycke m, tavernier r, le polain de waroux jb, duytschaever m, knecht s.Impact of catheter ablation on arrhythmia burden in patients with shock-resistant persistent atrial fibrillation.Jacc clin electrophysiol.2023 jul 18:s2405-500x(23)00390-0.Doi: 10.1016/j.Jacep.2023.06.004.Epub ahead of print.Pmid: 37542487.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 17959559
• MDR Text Key: 325972951
• Report Number: 2029046-2023-02359
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• 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 3 MAPPING SYSTEM; LASSO MAPPING CATHETER
• Patient Outcome(s): Hospitalization