MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Ventricular Fibrillation (2130); Pericardial Effusion (3271); Heart Block (4444)

Event Date 11/13/2021

Event Type  Death  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: rabah h, youness m, rabah a.Sensor enabled catheter ablation study (secas).Cureus.2021 nov 13;13(11):e19550.Doi: 10.7759/cureus.19550.Pmid: 34926037; pmcid: pmc8671080.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: rabah h, youness m, rabah a.Sensor enabled catheter ablation study (secas).Cureus.2021 nov 13;13(11):e19550.Doi: 10.7759/cureus.19550.Pmid: 34926037; pmcid: pmc8671080.Objective/methods/study data: background: ensite precision technology (abbott, (b)(4) is a novel mapping and navigation system facilitating the visualization and manipulation of intracardiac catheters during arrhythmia ablation procedures.When using sensor enabled (se) catheters (abbott, (b)(4)), the mapping system uses both electrical impedance and magnetic data to facilitate more accurate mapping and navigation.Whether this translates into better clinical outcomes is unknown.Methods: this retrospective study will examine whether se catheters improve the success rate or decrease the risks compared to biosense thermocool catheters (biosense webster inc., (b)(4)) not employing sensor-enabled technology utilizing navx ensite precision algorithms.Charts of 146 patients who underwent radiofrequency ablations for supraventricular and ventricular arrhythmias between 2016 and 2019 in the (b)(6) were reviewed and analyzed.It was concluded that se catheters have the same success rate as electrical impedance catheters.Results: a total of 70% of the ablations carried using the impedance-based catheter were successful compared to 74% using the se catheter.However, the difference was statistically non-significant (p-value: 0.7).As for complications, the ventricular fibrillation rate was increased in the se catheter group.Three procedures were complicated by pericardial effusion, three patients had reversible heart block, and one death was recorded, all reported while using the standard catheter (p-value: 0.01).-conclusion: se catheters have the same success rates compared to standard catheters using the ensite precision mapping system.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool; other biosense webster devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: ensite precision technology (abbott, (b)(4)); a sensor enabled (se) catheter (abbott, (b)(4)); navx se field scalin.Adverse event(s) and provided interventions: three patients had ventricular fibrillation (vf) requiring cardioversion; two procedures were complicated by pericardial effusion; three patients had reversible heart block; one death was recorded.

• Brand Name: UNK_THERMOCOOL SF NAV
• 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: 14649958
• MDR Text Key: 293683591
• Report Number: 2029046-2022-01250
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2022

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 Catalogue Number: UNK_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/09/2022
• 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: A SENSOR ENABLED (SE) CATHETER (ABBOTT); ENSITE PRECISION TECHNOLOGY (ABBOTT,); NAVX SE FIELD SCALIN
• Patient Outcome(s): Life Threatening; Death