MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: liu yy, du x, he l, liu t, chen n, hu r, ning m, lv q, dong jz, ma cs.Evaluation of safety and effectiveness on catheter ablation of atrial fibrillation in patients aged =(b)(6).Heart lung circ.2022 mar 15:s1443-9506(22)00051-8.Doi: 10.1016/j.Hlc.2022.02.003.Epub ahead of print.Pmid: 35304060.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: liu yy, du x, he l, liu t, chen n, hu r, ning m, lv q, dong jz, ma cs.Evaluation of safety and effectiveness on catheter ablation of atrial fibrillation in patients aged =(b)(6).Heart lung circ.2022 mar 15:s1443-9506(22)00051-8.Doi: 10.1016/j.Hlc.2022.02.003.Epub ahead of print.Pmid: 35304060.Objective/methods/study data: aims: the prevalence and incidence of atrial fibrillation (af) significantly increase with age.Catheter ablation is already recommended in the guidelines for this selected elderly population.This study aimed to explore the safety and effectiveness of af catheter ablation in patients aged =(b)(6).Methods: the data were based on the (b)(6) study.Patients with af aged =(b)(6) who received catheter ablation from august 2011 to december 2020 were selected.Catheter ablation included bilateral circumferential pulmonary vein antrum isolation with or without additional linear ablation.Patients were followed up every 6 months.Arrhythmia-free curves were generated using kaplan-meier analysis.Cox proportional hazards regression models were used to analyse the predictors for post-ablation recurrence.Results: a total of 270 patients were included in the study.Many patients had comorbidities: 73.7% had hypertension and 29.3% had diabetes mellitus.All patients achieved successful bilateral circumferential pulmonary vein antrum isolation.Total complications were noted in nine of 270 (3.3%) patients and nine of 286 (3.1%) ablation procedures.After the first ablation procedure, 74% of the whole cohort-78% patients with paroxysmal af, and 66% patients with persistent af - were free from atrial tachyarrhythmia at follow-up to 12 months.Patients with persistent af, longer af duration, and history of ischaemic stroke were more likely to have af recurrence.Conclusion: patients with af aged =(b)(6), although with many comorbidities, had low complication rates and favourable outcomes after catheter ablation.Catheter ablation was a safe and effective treatment to achieve sinus rhythm in the selected elderly patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navi-star thermo-cool.Thermo-cool smarttouch.Other biosense webster devices that were also used in this study: carto, pentaray, lasso.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: 1 ischemic stroke, 1 dvt, 3 cardiac tamponades, 2 thromboembolism.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• 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: 14640956
• MDR Text Key: 293622391
• Report Number: 2029046-2022-01243
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/08/2022

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_NAVISTAR THERMOCOOL
• 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: UNK_CARTO 3; UNK_LASSO; UNK_PENTARAY
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention