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

Catalog Number SMART TOUCH BIDIRECTIONAL SF

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Paralysis (1997); Stenosis (2263); Heart Block (4444)

Event Date 04/16/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: naeemah qj, komatsu y, nogami a, sekiguchi y, igarashi m, yamasaki h, shinoda y, aonuma k, ieda m.Catheter ablation of ventricular tachycardia in dilated-phase hypertrophic cardiomyopathy: substrate characterization and ablation outcome.Pacing clin electrophysiol.2022 apr 16.Doi: 10.1111/pace.14508.Epub ahead of print.Pmid: 35430753.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 4.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: naeemah qj, komatsu y, nogami a, sekiguchi y, igarashi m, yamasaki h, shinoda y, aonuma k, ieda m.Catheter ablation of ventricular tachycardia in dilated-phase hypertrophic cardiomyopathy: substrate characterization and ablation outcome.Pacing clin electrophysiol.2022 apr 16.Doi: 10.1111/pace.14508.Epub ahead of print.Pmid: 35430753.Objective/methods/study data: introduction: catheter ablation is a therapeutic option to suppress ventricular tachycardia (vt) in the setting of dilated-phase hypertrophic cardiomyopathy (dhcm).However, the characteristics of the arrhythmogenic substrate and the ablation out come are not fully illustrated.Method: a total of 23 ablation procedures for drug-refractory sustained monomorphic vts in 13 dhcm patients were performed.The distribution of vt substrate as endocardial or epicardial/intramural was based on detailed mapping and ablation response during vt.Result: two patients underwent ablation of sustained monomorphic vt that was not scar-mediated tachycardia.Of the remaining 11 patients, eight (73%) patients had vt substrate in the basal regions, most frequently at the epicardial and/or intramural basal antero-septum.None of the patients had vt substrate located at the lv inferolateral region.Ablation at the right ventricular septum and the aortic cusps was done in four and five patients, respectively.Other approaches including bipolar and chemical ablations, were done in three and two patients, respectively.Six (55%) out of 11 patients (two patients lost follow-up) had vt recurrence.All the six patients had basal substrate.However, anti-tachycardia pacing was sufficient for vt termination except in one patient.Conclusion: catheter ablation of vt in patients with dhcm is challenging because of the predominant basal anteroseptal epicardial/intramural location of arrhythmogenic substrate.An ablation approach from multiple sites and/or adjunctive interventional techniques are often required.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf; biosense webster.Other biosense webster concomitant devices that were also used in this study: carto 3.-decanav® biosense webster.Pentaray.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: a total of three adverse events were reported: one patient had complete atrioventricular block in whom dual chamber icd had already been implanted and upgraded to crtd after ablation procedure.One patient had acute left anterior desceding artery (lad) occlusion during bipolar ablation, which was treated successfully by stenting.(coronary artery stenosis).One patient developed transient phrenic nerve palsy during epicardial ablation.

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14788035
• MDR Text Key: 295056484
• Report Number: 2029046-2022-01417
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/23/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/23/2022
• 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: CARTO 3; DECANAV® BIOSENSE WEBSTER; PENTARAY
• Patient Outcome(s): Required Intervention