MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Vascular Dissection (3160); Heart Block (4444)

Event Date 09/28/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: dukkipati sr, nakamura t, nakajima i, oates c, narui r, tanigawa s, sljapic t, whang w, koruth js, choudry s, schaeffer b, fujii a, tedrow ub, sapp jl, stevenson wg, reddy vy.Intramural needle ablation for refractory premature ventricular contractions.Circ arrhythm electrophysiol.2022 may;15(5):e010020.Doi: 10.1161/circep.121.010020.Epub 2022 apr 27.Pmid: 35476455.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.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 reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: dukkipati sr, nakamura t, nakajima i, oates c, narui r, tanigawa s, sljapic t, whang w, koruth js, choudry s, schaeffer b, fujii a, tedrow ub, sapp jl, stevenson wg, reddy vy.Intramural needle ablation for refractory premature ventricular contractions.Circ arrhythm electrophysiol.2022 may;15(5):e010020.Doi: 10.1161/circep.121.010020.Epub 2022 apr 27.Pmid: 35476455.Objective and methods: background: frequent premature ventricular contractions (pvcs) are often amenable to catheter ablation.However, a deep intramural focus may lead to failure due to inability of standard ablation techniques to penetrate the focus.We sought to assess the efficacy and safety of infusion needle ablation (ina) for pvcs that are refractory to standard radiofrequency ablation.Methods: under 2 food and drug administration approved protocols, ina was evaluated in patients with frequent pvcs that were refractory to standard ablation.Initial targets for ablation were selected by standard mapping techniques.Ina was performed with a deflectable catheter equipped with an extendable/retractable needle at the tip that can be extended up to 12 mm into the myocardium and is capable of pacing and recording.After contrast injection for location assessment, radiofrequency ablation was performed with the needle tip using a temperature-controlled mode (maximum temperature 60 °c) with saline infusion from the needle.The primary end point was a decrease in pvc burden to <5000/24 hours at 6 months.The primary safety end point was incidence of procedure- or device-related serious adverse events.Results: at 4 centers, 35 patients (age 55.3±16.9 years, 74.2% male) underwent ina.The baseline median pvc burden was 25.4% (interquartile range, 18.4%-33.9%) and mean left ventricular ejection fraction was 37.7±12.3%.Delivering 10.3±8.0 ina lesions/patient (91% had adjunctive standard radiofrequency ablation also) resulted in acute pvc elimination in 71.4%.After a mean follow-up of 156±109 days, the primary efficacy end point was met in 73.3%.The median pvc burden decreased to 0.8% (interquartile range, 0.1%-6.0%; p<0.001).The primary safety end point occurred in 14.3% consisting of 1 (2.9%) heart block, 1 (2.9%) femoral artery dissection, and 3 (8.6%) pericardial effusions (all treated percutaneously).Conclusions: ina is effective for the elimination of frequent pvcs that are refractory to conventional ablation and is associated with an acceptable safety profile lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: 3.5-mm irrigated tip contact force sensing catheter: thermocool smarttouch.Other biosense webster devices that were also used in this study: carto 3d, multielectrode mapping catheter: pentaray nav.Non-biosense webster devices that were also used in this study: intracardiac electrograms were continuously recorded on an electrophysiology recording system¿either a labsystem pro (boston scientific) or cardiolab (general electric healthcare).Unknown needle ablation catheter: 8-f deflectable catheter with a distal bipole consisting of dome and ring lectrodes.Adverse event(s) and provided interventions: 3 pericardial effusions requiring pericardiocentesis.1 intermittent complete heart block during needle advancement: no treatment specified.1 femoral artery dissection requiring percutaneous intervention.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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: 16360482
• MDR Text Key: 309370052
• Report Number: 2029046-2023-00267
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• 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: 01/30/2023
• Was Device Evaluated by Manufacturer?: No
• 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: CARDIOLAB (GENERAL ELECTRIC HEALTHCARE).; CARTO 3D.; LABSYSTEM PRO (BOSTON SCIENTIFIC).; PENTARAY NAV.; UNKNOWN NEEDLE ABLATION CATHETER.
• Patient Outcome(s): Required Intervention; Life Threatening