MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number	UNK_SMART TOUCH BIDIRECTIONAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: van der heijden caj, weberndörfer v, vroomen m, luermans jg, chaldoupi sm, bidar e, vernooy k, maessen jg, pison l, van kuijk smj, la meir m, crijns hjgm, maesen b.Hybrid ablation versus repeated catheter ablation in persistent atrial fibrillation: a randomized controlled trial.Jacc clin electrophysiol.2023 jul;9(7 pt 2):1013-1023.Doi: 10.1016/j.Jacep.2022.12.011.Epub 2023 jan 18.Pmid: 36752455.Objective/methods/study data: background although catheter ablation (ca) is successful for the treatment of paroxysmal atrial fibrillation (af), results are less satisfactory in persistent af.Hybrid ablation (ha) results in better outcomes in patients with persistent atrial fibrillation (persaf), as it combines a thoracoscopic epicardial and transvenous endocardial approach in a single procedure.Objectives the purpose of this study was to compare the effectiveness and safety of ha with ca in a prospective, superiority, unblinded, randomized controlled trial.Methods forty-one ablation-naive patients with (long-standing)-persaf were randomized to ha (n ¼ 19) or ca (n ¼ 22) and received pulmonary vein isolation, posterior left atrial wall isolation and, if needed, a cavotricuspid isthmus ablation.The primary efficacy endpoint was freedom from any atrial tachyarrhythmia >5 minutes off antiarrhythmic drugs after 12 months.The primary and secondary safety endpoints included major and minor complications and the total number of serious adverse events.Results after 12 months, the freedom of atrial tachyarrhythmias off antiarrhythmic drugs was higher in the ha group compared with the ca group (89% vs 41%, p ¼ 0.002).There was 1 pericarditis requiring pericardiocentesis and 1 femoral arteriovenous-fistula in the ha group (associated with sheath that is not identified in the article).In the ca arm, 1 bleeding from the femoral artery occurred (associated with sheath that is not identified in the article).There were no deaths, strokes, need for pacemaker implantation, or conversions to sternotomy, and the number of (serious) adverse events was comparable between groups (21% vs 14%, p ¼ 0.685).Conclusions hybrid af ablation is an efficacious and safe procedure and results in better outcomes than catheter ablation for the treatment of patients with persistent af.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch ablation catheter.Other biosense webster devices that were also used in this study:carto with visitag 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 (pericarditis) requiring pericardiocentesis (recognized procedural complication).Additional information was received on 22-aug-2023.Author provided further details that the pericarditis was tamponade that required rehospitalization and re-operation with subxiphoidal drainage.The patient was hospitalized from (b)(6) 2017 until (b)(6) 2017 and then re-operation commenced on (b)(6) 2017.No further information can be provided on patient demographics or specific device identification.Authors also report that another adverse event can be possibly associated with a biosense webster device: 1 bleeding from the femoral artery in the catheter arm on (b)(6) 2017.Initial procedure took place on (b)(6) 2017.This adverse event is clinically associated with a utilization of a sheath during femoral vein/artery access.Authors indicate device identity information cannot be provided.Therefore, it is assumed that a biosense webster vizigo sheath was utilized.
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: van der heijden caj, weberndörfer v, vroomen m, luermans jg, chaldoupi sm, bidar e, vernooy k, maessen jg, pison l, van kuijk smj, la meir m, crijns hjgm, maesen b.Hybrid ablation versus repeated catheter ablation in persistent atrial fibrillation: a randomized controlled trial.Jacc clin electrophysiol.2023 jul;9(7 pt 2):1013-1023.Doi: 10.1016/j.Jacep.2022.12.011.Epub 2023 jan 18.Pmid: 36752455.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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same article.Manufacturer's ref #: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 17655988
• Report Number: 2029046-2023-01945
• Device Sequence Number: 7278702
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/30/2023

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: 08/04/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CARTO WITH VISITAG; UNK_CARTO VIZIGO SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown