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 Codes	Vasoconstriction (2126); Cardiac Tamponade (2226)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature citation has been reviewed: lin, y.-f.; xu, q.; zheng, c.;shao, j.-m.; shen, b.; he, r.-l.; lin,j.-f.; chen, y.-r.Electrocardiographic characteristics of ventricular arrhythmias originating from different areas adjacent to themitral annulus.J.Cardiovasc.Dev.Dis.2023, 10, 334.Https://doi.Org/ 10.3390/jcdd10080334 objective/methods/study data: this study aimed to explore the electrocardiographic (ecg) characteristics of ventricular arrhythmias (vas) arising from epicardial and endocardial areas adjacent to the mitral annulus (ma).Methods: this retrospective study analyzed 3435 patients referred for rfca for vas to the second affiliated hospital and yuying children¿s hospital of wenzhou medical university from january 2009 to september 2021.The origin sites were located in areas adjacent to the ma in 283 patients (8.24%).These 283 cases included 132 endocardium cases and 151 epicardium cases.The ecg characteristics of these patients were analyzed retrospectively.All cases had frequent pvcs/vt (defined as pvcs more than 10,000 counts/24 h) or severe clinical symptoms intolerable to at least two antiarrhythmic drugs (aads).Prior to ablation, aads were abandoned for at least five half-lives.Complete physical examination, echocardiography, or coronary angiography (8.83% cases underwent coronary angiography) proved no structural heart diseases in any patient lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermo-cool or smart touch, biosense webster, diamond bar, ca, usa) other biosense webster devices that were also used in this study: carto3, biosense webster, usa adverse event(s) and provided interventions: qty 3- pericardial effusion (from epicardium group, both improved after pericardiocentesis and corticosteroid therapy) qty 3- acute coronary artery injury or spasm; improved after intracoronary nitroglycerin injection.Qty 4- steam pops ( endocardium group).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature citation has been reviewed: lin, y.-f.; xu, q.; zheng, c.;shao, j.-m.; shen, b.; he, r.-l.; lin,j.-f.; chen, y.-r.Electrocardiographic characteristics of ventricular arrhythmias originating from different areas adjacent to themitral annulus.J.Cardiovasc.Dev.Dis.2023, 10, 334.Https://doi.Org/ 10.3390/jcdd10080334 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.The literature article cannot be attached as the electronic file size is too large.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: 17958867
• Report Number: 2029046-2023-02356
• Device Sequence Number: 5020854
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2023

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: 09/20/2023
• Initial Report FDA Received Date: 10/18/2023
• 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: CARTO3, BIOSENSE WEBSTER, USA
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown