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

Catalog Number	UNK_SMART TOUCH BIDIRECTIONAL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Heart Block (4444)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: olgun, f.E., kilicaslan, f.(2023).Rare thromboembolic complications of cavotricuspid isthmus ablation: single center experience.E journal of cardiovascular medicine 2023.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 the lot number was not 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 reference number: (b)(4).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: olgun, f.E., kilicaslan, f.(2023).Rare thromboembolic complications of cavotricuspid isthmus ablation: single center experience.E journal of cardiovascular medicine 2023.Objective/methods/study data: background: cavotricuspid isthmus (cti) - dependent atrial flutter (afl) is one of the most common supraventricular tachyarrhythmias.Catheter ablation (ca) for afl is an effective method of treatment and has been successfully used for 30 years.The most severe complications associated with ca include death, stroke, complete atrioventricular block, cardiac tamponade, acute myocardial infarction, and thromboembolism.The risk of developing ischemic stroke or pulmonary embolism (pe) from electrophysiologic procedures is reportedly 0% to 1.7%.Objective(s): the aim of this study was to share our experience with the rare thromboembolic complications of cavotricuspid isthmus ablation such as ischemic stroke and pulmonary embolism.Method(s): we retrieved our data about patients with afl who underwent cti ablation between 2020 and 2022 at our center.Inclusion criteria were documentation of standard 12-lead electrocardiographic (ecg) findings of isthmus-dependent afl or typical afl during the electrophysiological study.All interventions were performed with uninterrupted oral anticoagulation and transesophageal echocardiography was performed on patients who were in afl on the day of the procedure.The carto 3 (biosense webster, ca, usa) three-dimensional electroanatomic mapping system, a quadripolar ablation catheter (thermocool smarttouch catheter; biosense webster, ca, usa) through the steerable sheath flushed with heparinized saline were used.The clinical findings and treatments of patients who developed ischemic stroke or pulmonary embolism during and after the procedure were evaluated.Result(s): two hundred and nine patients (age 60.04+/-11.40 years) with afl were enrolled.Baseline characteristics of study population are summarized in table 1.Two patients (0.96%) developed thromboembolic complications during and after the procedure.In patient 1, pulmonary embolism presenting with dyspnea and complete av block occured at the second hour of the postoperative follow-up was treated without sequelae with temporary pacemaker implantation, noninvasive mechanical ventilation and heparin infusion.In patient 2, facial paralysis, left arm and left leg plegia occurred respectively during the placement of figure of eight suture in the groin.The patient was discharged without any sequelae after mechanical thrombectomy to the acute occlusion of the right medial cerebral artery by the interventional radiology team.Baseline clinical and procedural data of the 8 patients are summarized in table 2.Conclusion(s): ablation of cti for typical atrial flutter is safe and effective.Despite all precautions being taken, thromboembolic complications could be seen during the procedure and in the postoperative follow-up.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch catheter concomitant biosense webster devices that were used in this study: carto concomitant non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch catheter: qty 1 ¿ patient one developed (pulmonary embolism) and (heart block av) that required temporary pacemaker implantation (surgical intervention), noninvasive mechanical ventilation and heparin infusion qty 1 ¿ patient two: facial paralysis, left arm and left leg plegia occurred (cerebrovascular accident) and required mechanical thrombectomy to the acute occlusion of the right medial cerebral artery (surgical intervention).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION 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: 19611741
• Report Number: 2029046-2024-02086
• Device Sequence Number: 7097158
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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 BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/26/2024
• 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: CARTO
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown