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 Cardiac Tamponade (2226); Heart Block (4444)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: leyton-mange js, tandon k, sze ey, carpenter cm, sesselberg hw.The maine vein of marshall ethanol experience: learning curve and safety.J interv card electrophysiol.2023 apr;66(3):661-671.Doi: 10.1007/s10840-022-01378-8.Epub 2022 oct 1.Pmid: 36181632.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: leyton-mange js, tandon k, sze ey, carpenter cm, sesselberg hw.The maine vein of marshall ethanol experience: learning curve and safety.J interv card electrophysiol.2023 apr;66(3):661-671.Doi: 10.1007/s10840-022-01378-8.Epub 2022 oct 1.Pmid: 36181632.Objective/methods/study data:.The objective in this study is to understand the learning curve, and explore procedural outcomes and safety with vom ethanol infusion from a large single medical center.Methods one hundred twenty nine atrial ablation cases wherein vom ethanol infusion was attempted were identifed from the time of the program¿s inception in 2019 at maine medical center (portland, me).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: stsf.Exact quantities of products cannot be accurately determined as patients can experience more than adverse event and the data is summarized.Other biosense webster devices that were also used in this study: carto.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unknown smarttouch sf ablation catheter: qty 5 (cardiac tamponade) treated with pericardiocentesis (recognized procedural complication); qty 3 sinus nodal injury (heart block) eventually treated with implantation of pacemaker (surgical intervention.

• 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: 17135833
• MDR Text Key: 317241135
• Report Number: 2029046-2023-01300
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2023

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 Model Number: D134801
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/15/2023
• 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): Life Threatening; Required Intervention