MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number UNK_NAVISTAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 12/01/2017

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: field, yang long, yin yuehui, zhou song, liu qifang, wang yongmei, huang jing.Chinese circulation journal, december, 2017, vol.32 no.12 (serial no.234).Objective/methods/study data: objective: to investigate the safety and efficacy of carto three-dimensional mapping system combined with two modeling methods in radiofrequency ablation of paroxysmal atrial fibrillation.Methods: 150 patients with paroxysmal atrial fibrillation treated with radiofrequency ablation were randomly divided into three groups, group a (fig.N = 50): conventional point-to-point modeling guide heart circumferential pulmonary vein isolation for atrial fibrillation; group b (fig.N = 50): a left atrial and pulmonary vein model was constructed in a rapid anatomical modeling manner as a road mark to guide ablation for circumferential pulmonary vein ablation.Group c (fig.N = 50): the left atrial model was constructed by point-to-point mapping, and the circumferential pulmonary vein antrum was constructed with a rapid anatomical mapping method after the completion of pulmonary vein stoma to confirm the accuracy of the stoma followed by radiofrequency ablation for atrial fibrillation.The other intraoperative operation steps and methods were the same in the three groups.The operation time, x-ray exposure time, success rate and incidence rate of complications in the three groups were recorded, respectively.Echocardiography was used to measure left atrial size and left ventricular systolic function changes before and 6 months after surgery.Results: the operation time and x-ray exposure time in group c were significantly lower than those in groups a and b (fig.P < 0.05), and the power of group c was slightly higher than that of group a and b, but the difference was not statistically significant.No serious complications occurred in the three groups.Echocardiography showed no significant change in left atrial size and left ventricular fraction 6 months after operation.Conclusion: carto combined with radiofrequency ablation is safe and effective in guiding radiofrequency ablation of atrial fibrillation, which can reduce the operation time and x-ray exposure time, improve the accuracy of circumferential pulmonary vein stoma, and has certain guiding significance for radiofrequency ablation of atrial fibrillation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar, biosense.Webster.Johnson & johnson.Other biosense webster con concomitant devices that were also used in this study: carto and lasso catheter.Non-biosense webster concomitant devices that were also used in this study: f swartz l1 sheaths (st.Jude, usa).Adverse event(s) and provided interventions: 1 cardiac tamponade, 1 pulmonary vein stenosis, 1 thromboembolism (thrombosis), there was no mention of interventions provided.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: field, yang long, yin yuehui, zhou song, liu qifang, wang yongmei, huang jing.Chinese circulation journal, december, 2017, vol.32 no.12 (serial no.234).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.Manufacturer's reference number: (b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 15024962
• MDR Text Key: 295954782
• Report Number: 2029046-2022-01624
• Device Sequence Number: 1
• Product Code: DRF
• 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: 07/14/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/15/2022
• 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: CARTO; F SWARTZ L1 SHEATHS (ST. JUDE, USA); LASSO CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening