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 Transient Ischemic Attack (2109); Cardiac Tamponade (2226)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: tahin t, riba a, nemeth b, arvai f, lupkovics g, szeplaki g, geller l.Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures.Bmc cardiovasc disord.2021 aug 26;21(1):407.Doi: 10.1186/s12872-021-02219-8.Pmid: 34433424; pmcid: pmc8390247.Since no device has been received for analysis, 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 not provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: tahin t, riba a, nemeth b, arvai f, lupkovics g, szeplaki g, geller l.Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures.Bmc cardiovasc disord.2021 aug 26;21(1):407.Doi: 10.1186/s12872-021-02219-8.Pmid: 34433424; pmcid: pmc8390247.Objective/methods/study data: aim was to describe our experience in the implementation of an intracardiac echocardiography (ice) guided zero fluoroscopic (zf) ablation approach to our routine clinical practice.Simplified ice guided technique to perform ablation procedures for af, with the aid of a 3d electro anatomical mapping system.The workflow was implemented in two phases: the introductory phase, where the first 16 zf pvis were compared with 16 cases performed with fluoroscopy and the extension phase, where 71 consecutive patients (including repeat procedures) with zf approach were included.Standard pvi (and redo pvi) procedures were performed, data on feasibility of the zf approach, complications, acute and 1-year success rates were collected.Te study consisted of two main phases: the introductory phase, where the aim was to test the safety and feasibility of the zero-fluoroscopy (zf) technique versus the conventionally used, fluoroscopy guided (fl) workflow and the extension phase, where the longer-term outcomes were tested using the zf strategy in consecutive patients.A total of 103 patients were enrolled into the study between january 2017 and december 2018, who underwent catheter ablation by pulmonary vein isolation (pvi) for symptomatic, non-valvular atrial fibrillation at the centre.For the fl group the puncture was guided by fluoroscopy and ice.Both groups utilized biosense devices for mapping and ablation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: an irrigated contact force sensing ablation catheter (thermocool smarttouch¿ 8fr).Other biosense webster devices that were also used in this study: 20-pole lasso catheter, carto3¿ electro anatomical mapping system, a 10f ice catheter in the fl group only (accuson accunav).Non-biosense webster devices that were also used in this study: a decapolar reference catheter (dynamic deca, boston scientific).Adverse event(s) and provided interventions: qty 2 tamponades (both treated with pericardiocentesis and both discharged without additional treatment).Qty 1 tia noted after recovery from procedure but resolved by the following day without any residual symptoms (treatment not listed).

• 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: 12592597
• MDR Text Key: 277994389
• Report Number: 2029046-2021-01699
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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: 09/18/2021
• 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