MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 03/19/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: yang j, you l, liu m, zhang g, feng l, liu y, geng x, wu j, xie r.Impact of left atrial appendage closure combined with catheter ablation on endocrine and mechanical cardiac function in patients with atrial fibrillation.J interv cardiol.2022 mar 19;2022:3932912.Doi: 10.1155/2022/3932912.Pmid: 35360092; pmcid: pmc8957483.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: yang j, you l, liu m, zhang g, feng l, liu y, geng x, wu j, xie r.Impact of left atrial appendage closure combined with catheter ablation on endocrine and mechanical cardiac function in patients with atrial fibrillation.J interv cardiol.2022 mar 19;2022:3932912.Doi: 10.1155/2022/3932912.Pmid: 35360092; pmcid: pmc8957483.Objective/methods/study data: background: the combined procedure of left atrial appendage closure (laac) and catheter ablation (ca) is a safe and feasible therapy to treat patients with atrial fibrillation (af).However, the effect of the combined procedure on cardiac function remains unclear.& is study aimed to investigate the changes in endocrine and mechanical function of the heart following the combined procedure.Methods: this retrospective study included 62 consecutive patients who underwent the combined procedure of af ablation and watchman laac and 62 sex and age-matched patients who only received af ablation.During follow-up, patients were examined for brain natriuretic peptide (bnp) levels to represent endocrine cardiac function.Mechanical cardiac function was assessed during echocardiographic examination.No significant difference was observed between the two groups.Conclusions: the combined procedure of laac and ca significantly improved the endocrine and mechanical function of the heart.Compared to simple ca, based on ca with laac intervention, it does not significantly change la endocrine function but may lead to a decline in the la reservoir function.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smart-touch, biosense webster other biosense webster concomitant devices that were also used in this study: carto 3, biosense webster.Lasso® nav eco, biosense webster.Non-biosense webster concomitant devices that were also used in this study: watchman, boston scientific,(b)(6), usa adverse event(s) and provided interventions: there were two adverse events reported in the literature article: one patient had pericardial effusion requiring drainage.One patient experienced bleeding.

• Brand Name: THERMOCOOL SMARTTOUCH
• 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: 14639381
• MDR Text Key: 293851391
• Report Number: 2029046-2022-01232
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3; LASSO NAV ECO; WATCHMAN
• Patient Outcome(s): Life Threatening; Required Intervention