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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Paralysis (1997); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Laceration(s) of Esophagus (2398); Respiratory Tract Infection (2420); Thrombosis/Thrombus (4440)

Event Date 04/15/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: müller j, nentwich k, berkovitz a, ene e, sonne k, zhuravlev v, chakarov i, barth s, waechter c, behnes m, halbfass p, deneke t.Acute oesophageal safety and long-term follow-up of ai-guided high-power short-duration with 50 w for atrial fibrillation ablation.Europace.2023 apr 15;25(4):1379-1391.Doi: 10.1093/europace/euad053.Pmid: 36881791; pmcid: pmc10105862.Objective/methods/study data: this study aims to compare efficacy and safety of two different hpsd ablation approaches using different ablation index settings.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: müller j, nentwich k, berkovitz a, ene e, sonne k, zhuravlev v, chakarov i, barth s, waechter c, behnes m, halbfass p, deneke t.Acute oesophageal safety and long-term follow-up of ai-guided high-power short-duration with 50 w for atrial fibrillation ablation.Europace.2023 apr 15;25(4):1379-1391.Doi: 10.1093/europace/euad053.Pmid: 36881791; pmcid: pmc10105862.Objective/methods/study data:this study aims to compare efficacy and safety of two different hpsd ablation approaches using different ablation index settings.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: standard ablation catheter (thermocool smarttouch sf; biosense webster, irvine, california, usa).Other biosense webster devices that were also used in this study: electroanatomic mapping system (carto 3, biosense webster, diamond bar, ca, usa) in conjunction with a decapolar mapping catheter (lasso; biosense webster, diamond bar, ca, usa) or in selected patients with a multipolar high-density mapping catheter (pentaray; biosense webster, diamond bar, ca, usa), martablate generator (biosense webster, irvine, california, usa non-biosense webster devices that were also used in this study: steerable 11.7-french sheath was performed (agilis, abbott, minneapolis, mn, usa).Adverse event(s) and provided interventions: one pericardial tamponade three patients suffered thromboembolic complications (one transitory ischaemic attack 3 days after pvi without ct or mri imaging correlate; one patient with hemiparesis the day after pvi proven via ct and mri, and one patient with hemiplegia after the pvi proven with mri).Four patients suffered from post-conversion symptomatic bradycardia (unmasked sinus node dysfunction) and required pacemaker implantations after the ablation procedure.Four patients with aspiration pneumonia.Two patients with air embolism.One patient with phrenicus paresis - no treatment indicated.98 patients with edel or thermal oesophagus lesions -no treatment indicated.Two patients suffered from post-interventional stroke.One patient with hemiplegia with ischaemia - no treatment indicated.One patient with seizures with ischaemia - no treatment indicated.

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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: 17135339
• MDR Text Key: 317293252
• Report Number: 2029046-2023-01297
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• 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: DECAPOLAR MAPPING CATHETER (LASSO); ELECTROANATOMIC MAPPING SYSTEM (CARTO 3); MULTIPOLAR HIGH-DENSITY MAPPING CATH (PENTARAY); SMARTABLATE GENERATOR; STEERABLE 11.7-FRENCH SHEATH (AGILIS, ABBOTT,); UNK_SMARTABLATE PUMP
• Patient Outcome(s): Required Intervention; Life Threatening