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 Stroke/CVA (1770); Paralysis (1997); Paresis (1998); Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: okamatsu h, okumura k, kaneko s, negishi k, hayashi k, tsurugi t, tanaka y, nakao k, sakamoto t, koyama j.Ablation index-guided high-power radiofrequency application shortens the procedure time with similar outcomes to conventional power application in atrial fibrillation ablation.Circ rep.2021 sep 2;3(10):559-568.Doi: 10.1253/circrep.Cr-21-0099.Pmid: 34703933; pmcid: pmc8492404.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 #: pc-001138378.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: okamatsu h, okumura k, kaneko s, negishi k, hayashi k, tsurugi t, tanaka y, nakao k, sakamoto t, koyama j.Ablation index-guided high-power radiofrequency application shortens the procedure time with similar outcomes to conventional power application in atrial fibrillation ablation.Circ rep.2021 sep 2;3(10):559-568.Doi: 10.1253/circrep.Cr-21-0099.Pmid: 34703933; pmcid: pmc8492404.Objective/methods/study data: background: the impact of high-power radiofrequency (rf) application in ablation index (ai)-guided atrial fibrillation (af) ablation has not been elucidated.Methods and results: we investigated 1,333 patients undergoing first af ablation (median age 68 years; interquartile range [iqr] 61¿73 years).The first 301 patients underwent ai-guided conventional power rf application (cp group), whereas the following 1,032 patients underwent high-power rf application (hp group).The minimum ai target values were 400, 360, and 260 at the left atrial anterior wall, posterior wall, and esophagus, respectively.Rf power in the cp group was 30¿40, 20¿25, and 20 w at the anterior wall, posterior wall, and esophagus, respectively, compared with 50, 40, and 25, respectively, in the hp group.Procedure time was shorter in the hp than cp group (median 153 [iqr 129¿190] vs.180 (iqr 152¿229) min; p<0.0001).The percentage of first-pass pulmonary vein isolation (69% vs.73%; p=0.07) and all procedure-related complications (2.0% vs.3.4%; p=0.19) was similar.Kaplan-meier analysis showed similar recurrence-free survival (rfs) for all af types.Respective 1-year rfs in the cp and hp groups was 82% and 87% in paroxysmal af, 78% and 82% in persistent af, and 59% and 58% in long-standing persistent af.Conclusions: in ai-guided af ablation, high-power rf application shortens the procedure time without increasing complications and with similar outcomes.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch surround flow.Other biosense webster devices that were also used in this study: soundstar.Carto3 system.Pentaray nav catheter.Non-biosense webster devices that were also used in this study: beeat; japan lifeline, tokyo, japan.Sl0; st.Jude medical.Agilis; st.Jude medical).Adverse event(s) and provided interventions: patients suffered phrenic nerve injury occurred in.All phrenic nerve injuries occurred during svc isolation.All patients except for 1 were asymptomatic.9 patients suffered gastric hypomotility occurred.6 patients suffered perforation/ tamponade.1 patient suffered a stroke.6 patients experienced pericarditis there was no mention of intervention provided.

• 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: 14710371
• MDR Text Key: 295027439
• Report Number: 2029046-2022-01330
• 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: 06/15/2022

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: 05/20/2022
• Initial Date FDA Received: 06/16/2022
• 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: AGILIS, ST. JUDE MEDICAL; BEEAT, JAPAN LIFELINE, TOKYO, JAPAN; CARTO3 SYSTEM; PENTARAY NAV CATHETER; SL0, ST. JUDE MEDICAL; SOUNDSTAR
• Patient Outcome(s): Life Threatening