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 Arrest (1762); Cardiac Tamponade (2226); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: gardziejczyk p, piotrowski r, krynski t, sikorska a, kulakowski p, baran j.Bipolar catheter ablation with dedicated radiofrequency system for highly refractory ventricular arrhythmia-does the rate of success depend on arrhythmia origin? j cardiovasc electrophysiol.2024 jan 31.Doi: 10.1111/jce.16186.Epub ahead of print.Pmid: 38293729.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 Description

This complaint is from a literature source.The following literature cite has been reviewed: gardziejczyk p, piotrowski r, krynski t, sikorska a, kulakowski p, baran j.Bipolar catheter ablation with dedicated radiofrequency system for highly refractory ventricular arrhythmia-does the rate of success depend on arrhythmia origin? j cardiovasc electrophysiol.2024 jan 31.Doi: 10.1111/jce.16186.Epub ahead of print.Pmid: 38293729.Objective/methods/study data: introduction: despite rapid technological progress, some arrhythmias are still resistant to standard unipolar ablation.These include arrhythmias arising from the base of the heart, cardiac crux, or epicardium.Bipolar radiofrequency ablation (b-rfa) may be useful in some cases, however, data on the efficacy of this approach in various arrhythmia localizations are scarce.The aim of this study was to assess the efficacy of b-rfa in patients with ventricular arrhythmias originating from various locations, occurring refractory to standard unipolar ablation approaches.Methods: an observational, single center study was conducted over a 30-month period.B-rfa were performed using dedicated radio frequency (rf) generator and electroanatomic mapping system.Results: twenty-four procedures, in 23 patients with a median (range) of 1 (1-2) previously failed unipolar ablation procedures, were included in the final analysis.There were 12 ablations of ventricular arrhythmias originating from interventricular septum with an acute success rate of 75%, and 12 from left ventricular (lv) summit with an acute success rate of 58%.The midterm success rate (median interquartile range follow-up of 205 days [188-338]) was 66% and 50%, respectively.Conclusions: b-rfa is a promising method of catheter ablation for refractory cardiac arrhythmias.A higher success rate was observed in ablation for difficult ventricular arrhythmias originating from interventricular septal region than lv summit.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch ablation catheter concomitant biosense webster devices that were used in this study: carto mapping system concomitant non-biosense webster devices that were also used in this study: agilis sheath (abbott), cereblate cool passive catheter (osypka ag), hat 500 rf system (osypka ag) no device malfunctions reported.Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 1 - (cardiac tamponade) due to a rupture of the aortic non-coronary cusp (soft tissue injury) by ablation catheter in a patient with reduced lvef, syncope due to multiple pvc and recent history of sars-cov2 infection the complication occurred during performing retrograde access to the aortic root with thermocool smart touch d catheter.During the hooking maneuver, we observed displacement of the tip of ablation electrode beyond the aortic silhouette with no obvious high cf recorded.Cardio-pulmonary resuscitation (cardiac arrest) and pericardiocentesis was performed, but bleeding continued.The patient underwent urgent cardiac surgery (surgical intervention) and a noncoronary cusp rupture was diagnosed.Surgery was successful, however, the patient suffered persistent neurological deficit.Computed tomography performed after cardiac surgery excluded subsequent stroke as a cause of neurological deficit (neurological impairment).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18923747
• MDR Text Key: 337903763
• Report Number: 2029046-2024-00874
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AGILIS SHEATH (ABBOTT); CARTO MAPPING SYSTEM; CEREBLATE COOL PASSIVE CATHETER (OSYPKA AG); HAT 500 RF SYSTEM (OSYPKA AG)
• Patient Outcome(s): Required Intervention; Life Threatening