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 Problem Stroke/CVA (1770)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed li x, liu t, cui b, zhang j, chen y, wu g.Efficacy and safety ablation index-guided high-energy linear ablation for persistent atrial fibrillation: pvi plus linear ablation of mitral isthmus and posterior box isolation.J clin med.2023 jan 12;12(2):619.Doi: 10.3390/jcm12020619.Pmid: 36675552; pmcid: pmc9862717.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 li x, liu t, cui b, zhang j, chen y, wu g.Efficacy and safety ablation index-guided high-energy linear ablation for persistent atrial fibrillation: pvi plus linear ablation of mitral isthmus and posterior box isolation.J clin med.2023 jan 12;12(2):619.Doi: 10.3390/jcm12020619.Pmid: 36675552; pmcid: pmc9862717.Objective and methods: background: for patients with persistent atrial fibrillation (af), whether linear ablation should be performed remains controversial, and the efficacy and safety for ablation index (ai)-guided high-energy linear ablation of mitral isthmus (mi) and left atrial (la) posterior box isolation is still unclear.The aims of this study were to assess the feasibility and clinical success rate of pulmonary veins isolation (pvi) combined with linear ablation of la roof and posterior inferior (posterior wall isolation) and mi compare with the pvi-alone method in patients of persistent af.Methods and results: 362 consecutive persistent af patients were enrolled from two electrophysiology centers.A total of 200 cases were in pvi-plus group and 162 cases were in pvi-alone group.The pvi-alone group received wide circumferential isolation of both ipsilateral pulmonary veins.Pvi combined with linear ablation of left atrial posterior wall isolation (lapwi)and mi were performed in the pvi-plus group.The primary study end point was the first recurrence of an atrial arrhythmia.After 24 months, freedom from the primary endpoint was achieved in 73.5% of the patients in the pvi-plus group and 62.5% in the pvi-alone group (hazard ratio = 0.62, 95% confidence interval: 0.43-0.91, log rank p = 0.012).The procedure-related complication rates were 2.5% in pvi-plus group and 1.9% in pvi-alone group (p = 0.808).Conclusion: in this study, the ablation strategy of ablation (pvi plus linear ablation of mitral isthmus and posterior box isolation) was feasible and safe for persistent af patients.Compared with the pvi-alone method, it improved outcomes in patients with persistent af.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: thermocool smart-touch stsf.Other biosense webster devices that were also used in this study: carto 3, visitag module, and multipolar mapping catheter (pentaray).Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and interventions: 1 postoperative ischemic stroke who recovered without severe morbidity after unspecified treatment.

• 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: 16461661
• MDR Text Key: 310452660
• Report Number: 2029046-2023-00418
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• 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: 02/01/2023
• 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_CARTO 3; UNK_PENTARAY; UNK_VISITAG SURPOINT¿ EPU
• Patient Outcome(s): Life Threatening