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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pseudoaneurysm (2605); Heart Block (4444); Pericarditis (4448)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

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 provided by the customer.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 Description

This complaint is from a literature source.The following literature cite has been reviewed: karkowski g, kuniewicz m, kozluk e, chyzy t, zabek a, dusza m, lelakowski j.Non-fluoroscopic radiofrequency catheter ablation of right- and left-sided ventricular arrhythmias.Postepy kardiol interwencyjnej.2020 sep;16(3):321-329.Doi: 10.5114/aic.2020.99268.Epub 2020 oct 2.Pmid: 33597998; pmcid: pmc7863801.Objective/methods/study data: this study includes 128 patients who underwent radiofrequency catheter ablation of ventricular arrhythmias from 2014 to 2018.Patients were divided into two groups: non-fluoroscopic - radiofrequency catheter ablation and fluoroscopic- radiofrequency catheter ablation.Patients in each group were then subsequently subdivided into two groups based on ventricular arrhythmias localization ¿ left- (ls-va) and right-sided (rs-va) ventricular arrhythmias.The aim of this study was the analysis of safety and effectiveness of non-fluoroscopic- radiofrequency catheter ablation of ventricular arrhythmias from left- and right-sided cardiac chambers.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch.Concomitant other biosense webster devices that were also 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: there were 4 (4.6%) perioperative complications in non-fluoroscopic - radiofrequency catheter ablation.Qty 1: pseudoaneurysm after femoral artery access, treated by thrombin injection.Qty 1: first degree of atrioventricular block after ectopic ventricular ablation.Qty 1: pericarditis after ablation, that required pharmacotherapy.Qty 1: pericarditis after ablation, that required pericardiocentesis because of the symptomatic pericardial effusion.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13935855
• MDR Text Key: 289776239
• Report Number: 2029046-2022-00658
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening