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

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 01/09/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: li x, chen y, chen g, deng c, tang c, zhang j.Single ring isolation of pulmonary veins combined with electrical isolation of the superior vena cava in patients with paroxysmal atrial fibrillation.Front cardiovasc med.2023 jan 9;9:1028053.Doi: 10.3389/fcvm.2022.1028053.Pmid: 36698934; pmcid: pmc9869763.Objective and methods: single-ring isolation (sri) of the pulmonary veins and the left atrial post wall (lapw) is an accepted strategy in atrial fibrillation ablation.Whether sri combined with superior vena cava isolation (svci) could further increase the success rate of paroxysmal atrial fibrillation (paf) has not been reported.This study aimed to investigate whether sri combined with svci was feasible and whether it could improve the success rate of paf ablation in 60 patients who received ablation between may 2019 and march 2021.Sri plus svci was completed with ablation index (ai)-guided high-power ablation.The success rates of sri and svci were 100% and 97%, respectively.One-pass sri was achieved in 41 out of 60 patients, with 19 out of 60 patients requiring additional ablation to complete the sri.After ablation, one patient had an ischemic stroke but recovered without severe morbidity.The average follow-up period was (20 ± 7) months, and single-procedure freedom from atrial arrhythmia was 91.7%.At/af recurred in five patients, and 2 out of 5 patients underwent redo ablation.The multi-procedure freedom from atrial arrhythmia was 95%.Any adverse events associated with competitor or unknown products or attributed to the patient¿s preexisting conditions are excluded.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: thermocool smarttouch stsf: irrigated tip ablation catheter other biosense webster devices that were also used in this study: carto 3 pentaray visitag module.Non-biosense webster devices that were also used in this study: unk sheath adverse event(s) and interventions: 1 postoperative ischemic stroke.Patient recovered fully after unspecified medical intervention.

Manufacturer Narrative

Manufacturer's ref no.: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: li x, chen y, chen g, deng c, tang c, zhang j.Single ring isolation of pulmonary veins combined with electrical isolation of the superior vena cava in patients with paroxysmal atrial fibrillation.Front cardiovasc med.2023 jan 9;9:1028053.Doi: (b)(6).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 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: field "d4.Catalog" should be "unk_smart touch bidirectional sf".

• 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: 17183156
• MDR Text Key: 317722796
• Report Number: 2029046-2023-01352
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/22/2023

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: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/22/2023
• 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: UNK SHEATH; UNK_CARTO 3; UNK_PENTARAY; UNK_SMART TOUCH BIDIRECTIONAL SF; UNK_THERMOCOOL SF NAV; UNK_VISITAG SURPOINT¿ EPU
• Patient Outcome(s): Life Threatening; Required Intervention