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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Paralysis (1997); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source: hayasaka k, sasaki t, shirai y, shimosato h, tahara t, segami s, nagasawa r, akimoto k, yabe k, toya c, watanabe k, yamashita s, suzuki m, sugiyama k, yamauchi y, okishige k, goya m, sasano t.A novel catheter ablation strategy for non-paroxysmal atrial fibrillation combining cryoballoon, radiofrequency, and marshall-vein ethanol ablations.Pacing clin electrophysiol.2023 may 2.Doi: 10.1111/pace.14709.Epub ahead of print.Pmid: 37129189.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was not 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.Note: the literature article's electronic file size is too large to be attached and submitted.

Event Description

This complaint is from a literature source: hayasaka k, sasaki t, shirai y, shimosato h, tahara t, segami s, nagasawa r, akimoto k, yabe k, toya c, watanabe k, yamashita s, suzuki m, sugiyama k, yamauchi y, okishige k, goya m, sasano t.A novel catheter ablation strategy for non-paroxysmal atrial fibrillation combining cryoballoon, radiofrequency, and marshall-vein ethanol ablations.Pacing clin electrophysiol.2023 may 2.Doi: 10.1111/pace.14709.Epub ahead of print.Pmid: 37129189.Objective/methods/study data:this study aims to investigate the efficacy and safety of a novel extensive ablation strategy for non-paf, that is based on a combination of cryoballoon (cba), radiofrequency (rfa), and marshall-vein ethanol ablations (ea-vom).The study was a single-center, retrospective observational study.We enrolled 171 consecutive patients who underwent de-novo catheter ablation for nonpaf under conscious sedation with a novel extensive ablation strategy that included cba for pulmonary vein isolation (pvi) and left atrial roof ablation (lara), rfa for mitral isthmus (mi) ablation, superior vena cava isolation, and other linear ablations and ea-vom.Recurrence of atrial arrhythmias over 1 year, procedure outcomes, and procedure-related complications were investigated.:a total of 139 (81.3%) patients remained in sinus rhythm during 1-year followup.Of the 139 patients, 51 patients (29.8%) received antiarrhythmic drugs.The mean procedure time was 204 ± 45 min.Pvi and lara ablation by cba and mi block by rfa and ea-vom were completed in 171 (100%) and 166 (97.1%) patients, respectively.No serious procedure-related complications were observed except for one case of delayed pericardial effusion.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: (carto3, biosense webster, diamond bar, ca) non-biosense webster devices that were also used in this study: sheath (agilis, abbott, st.Paul, mn), 28-mm cryoballoon (arctic front advance,medtronic, mn), steerable sheath (flexcath advance, medtronic), mapping catheter (achieve, medtronic), 7fr inner guiding catheter with 90-angled tip (attain select ii sv(6248vi-90s); medtronic), adverse event(s) and provided interventions: qty 17- mild pericardial effusion not requiring drainage qty 1- delayed pericardial effusion requiring drainage qty 10- transient phrenic nerve palsy.

• 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: 17167901
• MDR Text Key: 317581817
• Report Number: 2029046-2023-01329
• 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: 06/20/2023

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: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/20/2023
• 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: 28-MM CRYOBALLOON ARCTIC FRONT ADVANCE; 28-MM CRYOBALLOON MN; 28-MM CRYOBALLOON MEDTRONIC; 7FR INNER GUIDING CATHETER WITH 90¿-ANGLED TIP; CA; CARTO3, BIOSENSE WEBSTER; DIAMOND BAR; MAPPING CATHETER MEDTRONIC; MAPPING CATHETER ACHIEVE; SHEATH AGILIS, ABBOTT; SHEATH MN; SHEATH ST. PAUL; STEERABLE SHEATH MEDTRONIC; STEERABLE SHEATH FLEXCATH ADVANCE; SV(6248VI-90S), MEDTRONIC),
• Patient Outcome(s): Required Intervention; Life Threatening