MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Transient Ischemic Attack (2109); Cardiac Tamponade (2226)

Event Date 10/08/2020

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: schade a, costello-boerrigter l, steinborn f, bayri ah, chapran m, surber r, schulze pc, mattea v.Voltage-guided ablation in persistent atrial fibrillation-favorable 1-year outcome and predictors.J interv card electrophysiol.2021 nov;62(2):249-257.Doi: 10.1007/s10840-020-00882-z.Epub 2020 oct 8.Pmid: 33030630.Objective/methods/study data: introduction pulmonary vein isolation (pvi) in persistent atrial fibrillation (af) has a low success rate.A newer ablation concept targets left atrial (la) low voltage zones (lvz) which correlate with fibrosis and predict recurrence after pvi.We aimed to determine the success of combined pvi- and lvz-guided ablation and to identify the predictors for lvz and for ablation success.Methods and results a total of 119 consecutive patients who underwent their first ablation procedure due to persistent af were included.After acquisition of a high-resolution la voltage map, pvi- and lvz-guided ablation were performed.Mean age was 69 ± 8 years, 53%were men, and 8% had longstanding persistent af.We found lvz in 55%of patients.Twelve-month freedom from recurrences off drugs was 69%.Conclusion lvz-guided ablation in combination with pvi results in comparably high success rates.However, the existence of lvz remains the strongest predictor of ablation success.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Other biosense webster devices that were also used in this study: carto.Lasso.Non-biosense webster devices that were also used in this study: agilis®, abbott, plymouth, minn, usa).Adverse event(s) and provided interventions: there were two reported adverse events possibly related to bwi devices: (1) pericardial tamponade.(1) transient ischemic attack.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: schade a, costello-boerrigter l, steinborn f, bayri ah, chapran m, surber r, schulze pc, mattea v.Voltage-guided ablation in persistent atrial fibrillation-favorable 1-year outcome and predictors.J interv card electrophysiol.2021 nov;62(2):249-257.Doi: 10.1007/s10840-020-00882-z.Epub 2020 oct 8.Pmid: 33030630.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).

• Brand Name: UNK_THERMOCOOL SF NAV
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14640881
• MDR Text Key: 293852351
• Report Number: 2029046-2022-01239
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/08/2022

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_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/09/2022
• 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®, ABBOTT, PLYMOUTH, MINN, USA; UNK_CARTO 3; UNK_LASSO
• Patient Outcome(s): Required Intervention; Life Threatening