MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH UNIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Pseudoaneurysm (2605)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: cano ó, pérez-roselló v, ayala hd, izquierdo m, osca j, sancho-tello mj, martínez-dolz l.Influence of baseline inducibility and activation mapping on ablation outcomes in patients with structural heart disease and ventricular tachycardia.J cardiovasc electrophysiol.2021 may;32(5):1328-1336.Doi: 10.1111/jce.15035.Epub 2021 apr 16.Pmid: 33834564.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.Manufacturer's reference number: (b)(4).

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: cano ó, pérez-roselló v, ayala hd, izquierdo m, osca j, sancho-tello mj, martínez-dolz l.Influence of baseline inducibility and activation mapping on ablation outcomes in patients with structural heart disease and ventricular tachycardia.J cardiovasc electrophysiol.2021 may;32(5):1328-1336.Doi: 10.1111/jce.15035.Epub 2021 apr 16.Pmid: 33834564.Objective and methods: stand-alone substrate ablation has become a standard ventricular tachycardia (vt) ablation strategy.The authors sought to evaluate the influence of baseline vt inducibility and activation mapping on ablation outcomes in patients with structural heart disease (shd) undergoing vt ablation.The purpose of this single center, observational and retrospective study including 160 consecutive patients with shd and documented vt undergoing ablation between march 2011 and september 2019.Baseline vt induction was attempted before ablation in all patients and vt activation mapping performed when possible.Ablation was guided by activation mapping for mappable vts plus substrate ablation for all patients.Ablation outcomes and complications were evaluated.The patients were divided into three groups according to baseline vt inducibility: group 1 (non inducible, n = 18), group 2 (1 vt morphology induced, n = 53), and group 3 (>1 vt morphology induced, n = 89).Patients who had preexisting hemodynamic instability and/or heart failure were placed on ecmo during the procedure.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: contact-force (cf) ablation catheter: smarttouch, biosense webster.Pentaray multi electrode diagnostic catheter.Smarttouch linear diagnostic catheter.Other biosense webster devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: all associated with the lapwi procedure.N/a.Adverse event(s) and provided interventions: 4 instances of cardiac tamponade treated with pericardiocentesis.3 arterial pseudoaneurysms: 2 treated with surgery and 1 treatment unknown.1 femoral hematoma- no treatment required.9 patients with acute hemodynamic decompensation treated with inotropic drugs.Of these 9, two died due to refractory cardiogenic shock associated with lvad implantation and one after cardiac transplantation.The authors do not attribute these deaths to the devices or the procedure.1 patient died after an acute coronary occlusion (proximal left anterior descending artery) during the procedure which was immediately stented but resulting in refractory cardiogenic shock.The manufacturer of the stent was unknown.".

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL SF
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12580528
• MDR Text Key: 275185433
• Report Number: 2029046-2021-01674
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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: 09/13/2021
• 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