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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Hematoma (1884)

Event Date 11/25/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed kitai t, kasai y, kasai j, morita j, fujita t.Mediastinal hematoma associated with radiofrequency catheter ablation of atrial fibrillation.Circ j.2022 nov 25;86(12):2041.Doi: 10.1253/circj.Cj-22-0174.Epub 2022 aug 11.Pmid: 35965067 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 no 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.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed kitai t, kasai y, kasai j, morita j, fujita t.Mediastinal hematoma associated with radiofrequency catheter ablation of atrial fibrillation.Circ j.2022 nov 25;86(12):2041.Doi: 10.1253/circj.Cj-22-0174.Epub 2022 aug 11.Pmid: 35965067.Objective and methods: 54-year-old male underwent radiofrequency (rf) catheter ablation for atrial fibrillation with the carto system and a non-contact force-sensing ablation catheter (thermocool surround flow) under deep sedation.Pulmonary vein isolation (pvi) was performed using computed tomography (ct) merge to avoid rf application near the esophagus and ablation was applied to the la posterior wall.3 months after the procedure, the patient was experiencing dysphagia.A ct scan and endoscopy revealed a mediastinal mass between the la and descending aorta.Fine needle aspiration indicated the mass was a hematoma from the ablation procedure.Patient was treated with coronary stenting preceded by dual antiplatelet therapy.At five months, the hematoma had shrunk.There was no additional treatment indicated in the article.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.Non-biosense webster devices that were also used in this study: na.Adverse event(s) and interventions: 1 report of dysphagia secondary to mediastinal hematoma at the la and descending aorta ablation site treated with antiplatelet therapy and an additional surgical coronary stenting procedure.

• 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: 16462116
• MDR Text Key: 310463165
• Report Number: 2029046-2023-00422
• 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,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 Model Number: D134801
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL SF
• 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: CARTO.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male