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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced atrial tachycardia and heart failure that required repeat ablation.The patient was referred to the hospital for heart failure concurrent with persistent atrial fibrillation (afib).After the treatment of heart failure and introduction of rate control medications, catheter ablation (ca) of persistent afib was scheduled.During the first session, extensive encircling pulmonary vein isolation (pvi) and cavotricuspid isthmus ablation were performed under the guidance of an electroanatomical mapping system.Subsequently, the left atrial voltage was evaluated using a multielectrode catheter under sinus rhythm.Extensive left atrial low-voltage areas (lvas) (<0.5 mv) were observed on the anterior wall and septum of the left atrium.Then, lva homogenization was performed using the point-by-point method ablation.Radiofrequency (rf) energy was delivered to the lva until reaching an ablation index = 350 with a distance between tags < 6 mm.Six months after the first session and sinus rhythm restoration, the functional status significantly improved from new york heart association class iii to class i.The left ventricular ejection fraction increased from 30 % to 60 %, and the plasma n-terminal probrain natriuretic peptide level decreased from 2490 to 598 pg/dl.However, relapse of the heart failure symptoms was observed at the 1-year follow-up examination.Twelve lead electrocardiography showed sustained at with intermittent atrioventricular conduction with a ventricular rate of 110 bpm.This atrial tachycardia (at) would have been a major contributor to the development of heart failure in this patient; thus, a second ablation treatment was performed.The physician¿s comment about the cause of the event: previous lva-guided ablation unintentionally generated slow conduction zones and resulted in an iatrogenic atrial tachycardia (at) 1 year after homogenization of lvas.There were no abnormalities observed before or while using the product.Patient fully recovered.

Manufacturer Narrative

D 4.Catalog: unk_smart touch bidirectional.E 1.Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore 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 provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

• 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: 18619000
• MDR Text Key: 334258227
• Report Number: 2029046-2024-00366
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female