MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Hematoma (1884); Paralysis (1997); Cardiac Tamponade (2226); Ischemic Heart Disease (2493); Heart Block (4444)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: fernandez-armenta j, soto-iglesias d, silva e, penela d, jáuregui b, linhart m, bisbal f, acosta j, fernandez m, borras r, villuendas r, cano l, guasch e, mont l, berruezo a.Safety and outcomes of ventricular tachycardia substrate ablation during sinus rhythm: a prospective multicenter registry.Jacc clin electrophysiol.2020 oct 26;6(11):1435-1448.Doi: 10.1016/j.Jacep.2020.07.028.Pmid: 33121673.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter (d133601) approved under pma # p030031/s053.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 not provided by the customer.Biosense webster manufacturer's reference number pc-(b)(4).Has two reports: (1) mfr # 2029046-2022-02431 for product code unk (similar device to thermocool® smart touch¿ electrophysiology catheter) (2) mfr # 2029046-2022-02429 for product code unk (similar device to thermocool® smart touch¿ electrophysiology catheter).

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: fernandez-armenta j, soto-iglesias d, silva e, penela d, jáuregui b, linhart m, bisbal f, acosta j, fernandez m, borras r, villuendas r, cano l, guasch e, mont l, berruezo a.Safety and outcomes of ventricular tachycardia substrate ablation during sinus rhythm: a prospective multicenter registry.Jacc clin electrophysiol.2020 oct 26;6(11):1435-1448.Doi: 10.1016/j.Jacep.2020.07.028.Pmid: 33121673.Objective/methods/study data: this study sought to analyze safety and outcomes of ventricular tachycardia (vt) substrate ablation during sinus rhythm (sr), without baseline vt induction.All consecutive patients (n ¼ 412) undergoing scar-related vt ablation in 6 centers were included.This is a prospective multicenter observational study of substrate-guided vt ablation during sinus rhythm.The aim of this registry is to evaluate the safety and short- and long-term outcomes of vt substrate ablation, by means of scar dechanneling, in patients with shd following an ablation protocol starting with substrate ablation during stable rhythm (sinus or paced).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool navistar or smarttouch, biosense webster-- for reportability purposes, this will be coded as unk_smart touch unidirectional.Other biosense webster devices that were also used in this study: carto 3 ,multipolar catheter (pentaray, biosense webster) non-biosense webster devices that were also used in this study: brk needle, medtronic, minneapolis, minnesota), ciirco probe englewood, arctic front advance medtronic, spiral mapping catheter( achieve medtronic).Adverse event(s) and provided interventions: qty 3 severe acute hemodynamic decompensation resolved with standard support measures and required procedure termination ( coded as cardiac arrest requiring cpr).Qty 6- heart block -no further information provided regarding interventions or outcome.Qty 5- puncture hematoma -no further information provided regarding interventions or outcome.Qty 6- cardiac tamponade -no further information provided regarding interventions or outcome.Qty 3- stroke/tia -no further information provided regarding interventions or outcome.Qty 3- phrenic nerve palsy -no further information provided regarding interventions or outcome.Qty 1- transient st-segment elevation -no further information provided regarding interventions or outcome.Qty 1- death due to pulseless electrical activity not responding to advanced resuscitation maneuvers.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15565403
• MDR Text Key: 301500210
• Report Number: 2029046-2022-02431
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031/S053
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• 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: BRK NEEDLE, MEDTRONIC, MINNEAPOLIS, MINNESOTA); CIIRCO PROBLE ENGLEWOOD, ARCTIC FRONT ADVANCE; MULTIPOLAR CATHETER (PENTARAY, BIOSENSE WEBSTER); SPIRL MAPPING CATHETER( ACHIEVE MEDTRONIC); UNK_CARTO 3
• Patient Outcome(s): Life Threatening