MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bradycardia (1751)

Event Date 06/01/2020

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: li teng huang jun liang jian bin wugang li chaofan li yifu.( june 2020).Efficacy of high-density substrate mapping with pentaray electrode in guiding catheter ablation of persistent atrial fibrillation.J clin med 2020 jun 37 issue 6 j clin intern med, vol.37, no.6.[doi] 10.3969/j.Issn.1001-9057.2020.06.012 http ://www.Lcnkzz.Com/cn/10.3969/j.Issn.1001-9057.2020.06.012.Objective/methods/study data: objective to investigate the efficacy and safety of catheter ablation of persistent atrial fibrillation (af) guided by high-density substrate mapping with pentaray electrode.Methods sixty patients with persistent atrial fibrillation were randomly divided into two groups: pulmonary vein isolation (pvi) plus left atrial voltage matrix mapping guided ablation group (observation group, n = 30) and pvi plus empirical linear ablation group (control group, n = 30).In the observation group, pentaray electrode was used to complete left atrial matrix mapping under sinus rhythm after electrical cardioversion.The ray time, operation time and ablation time were compared between the two groups.Kaplan-meier the sinus rhythm maintenance rate after ablation was analyzed and compared between the two groups.Results the operation time and ablation time in the observation group were significantly higher than those in the control group (p < 0.001), but there was no significant difference in the radiation time between the observation group and the control group (fig.P > 0.05).Patients in both groups were followed up for an average of 12 months, i.E.Kaplan-meier the results of curve analysis showed that the sinus rhythm maintenance rate was 76.6% in the study group and 76.7% in the control group.7% (23/30), 80.0% (24/30), the difference was not statistically significant (fig.P = 0.77), and no serious complications occurred in the two groups.Conclusion pentaray the sinus rhythm maintenance rate of the catheter ablation strategy for persistent atrial fibrillation guided by electrode high-density substrate mapping was not lower than that of pvi plus empirical linear ablation, and the operation time and ablation time were shorter.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch, johnson & johnson.Other biosense webster concomitant devices that were also used in this study: pentaray and carto 3, usa.Non-biosense webster concomitant devices that were also used in this study: n/a.Adverse event(s) and provided interventions: one patient in the control group was implanted with a dual-chamber cardiac pacemaker due to symptomatic sinus bradycardia after ablation.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: li teng huang jun liang jian bin wugang li chaofan li yifu.( june 2020).Efficacy of high-density substrate mapping with pentaray electrode in guiding catheter ablation of persistent atrial fibrillation.J clin med 2020 jun 37 issue 6 j clin intern med, vol.37, no.6.[doi] 10.3969/j.Issn.1001-9057.2020.06.012 http ://www.Lcnkzz.Com/cn/10.3969/j.Issn.1001-9057.2020.06.012.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 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.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15090507
• MDR Text Key: 296468618
• Report Number: 2029046-2022-01690
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2022

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: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/24/2022
• 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, USA; PENTARAY
• Patient Outcome(s): Required Intervention