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

Catalog Number	UNK_SMART TOUCH UNIDIRECTIONAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Stroke/CVA (1770); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: jiang z, guo c, liu q, tian y, tian l, yang y, wang j, chen c, zheng y, li y, ou q, yang l.Outcomes of single-procedure radiofrequency catheter ablation for idiopathic ventricular arrhythmias: a single-centre retrospective cohort study.Bmj open.2024 feb 20;14(2):e081815.Doi: 10.1136/bmjopen-2023-081815.Pmid: 38382956; pmcid: pmc10882318.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).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: jiang z, guo c, liu q, tian y, tian l, yang y, wang j, chen c, zheng y, li y, ou q, yang l.Outcomes of single-procedure radiofrequency catheter ablation for idiopathic ventricular arrhythmias: a single-centre retrospective cohort study.Bmj open.2024 feb 20;14(2):e081815.Doi: 10.1136/bmjopen-2023-081815.Pmid: 38382956; pmcid: pmc10882318.Objective/methods/study data: objectives: radiofrequency catheter ablation is the first-line treatment for idiopathic premature ventricular complexes (pvcs) and ventricular tachycardias (vts).However, the outcomes were less compared among the categories.The study aims to assess the effectiveness and safety of catheter ablation for idiopathic pvc/vts in a single high-volume centre, using the right ventricular outflow tract (rvot) as a reference.Design: retrospective cohort study.Setting: patient data were collected from a tertiary hospital in guizhou, china.Participants: between september 2013 and september 2022, 1028 patients (male: 41.3%; age: 46.5±15.6 years) who underwent the first catheter ablation for idiopathic monomorphic pvc/vts were enrolled.Outcome measures: acute success, procedure-related complications, and long-term recurrence were assessed.Antiarrhythmic drugs (aads) were not administrated after procedures unless recurrence was identified.Results: the overall acute success rate was 90.3%, with 368 patients (35.8%) experiencing left ventricular pvc/vts.No cases of third-degree atrioventricular block or death were reported.Complications were more common in patients with left ventricular pvc/vts than those with right-sided ones (4.6% vs 0.1%, p<0.001).A total of 926 patients (90.1%) were followed up for an average of 9.7±3.7 months, and only the pvc/vts category was found to be associated with long-term success rates.The rvot, endocardial left ventricular outflow tract (endolvot), tricuspid annulus (ta) free wall, posterior septum and fascicular vt had long-term success rates exceeding 85%.Other types of pvc/vts showed significantly higher risks of recurrence.Conclusions: besides rvot and fascicular vt, single-procedure catheter ablation without aads is highly effective for endolvot, ta-free wall and posterior septum.Patients with left ventricular pvc/vts have higher complication risks compared with right ones.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: navistar thermocool, carto 3 system non-biosense webster devices that were also used in this study: n/a although vascular complications were reported, such as pseudoaneurysm and arteriovenous fistula, the sheath that was used is unknown.Adverse event(s) and provided interventions possibly associated with unidentified smarttouch: qty 1: ischaemic stroke (cerebrovascular accident) (recognized procedural complication) (adverse event) qty 6: tamponades recovered by pericardial drainages.(cardiac tamponade) (recognized procedural complication) (adverse event) qty 1: one patient with cardiac perforation (cardiac perforation) at the lv apex survived by emergent open-chest repair.(surgical intervention) (adverse event).
Additional Manufacturer Narrative
During an internal review on (b)(6)2027, noted a correction to the 3500a initial under h6.Type of investigation, h6.Investigation findings and h6.Investigation conclusions.Therefore, processed accordingly.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 19619014
• Report Number: 2029046-2024-02100
• Device Sequence Number: 7097026
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNK_CARTO 3.; UNK_NAVISTAR THERMOCOOL.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown