MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Paralysis (1997); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: yan qd, gong kz, chen xh, chen jh, xu z, wang ww, zhang fl.Comparison of second-generation cryoballoon ablation and quantitative radiofrequency ablation guided by ablation index for atrial fibrillation.Bratisl lek listy.2023 jan 4.Doi: 10.4149/bll_2023_023.Epub ahead of print.Pmid: 36598303.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: yan qd, gong kz, chen xh, chen jh, xu z, wang ww, zhang fl.Comparison of second-generation cryoballoon ablation and quantitative radiofrequency ablation guided by ablation index for atrial fibrillation.Bratisl lek listy.2023 jan 4.Doi: 10.4149/bll_2023_023.Epub ahead of print.Pmid: 36598303.Abstract: background: radiofrequency ablation and cryoballoon ablation are the main methods of catheter ablation for patients with atrial fi brillation (af).However, different ablation catheters have different effi cacy and complication rates.This study aimed to compare the effi cacy and complication rates of quantitative radiofrequency ablation guided by ablation index ( rfca-ai) with those of second-generation cryoballoon ablation (cba-2).Methods: a total of 230 consecutive patients with symptomatic af undergoing a fi rst ablation procedure of cba-2 (92 patients) or rfca-ai (138 patients) were enrolled in this study.Results: the late recurrence rate in the cba-2 group was higher than that in the rfca-ai group (p=0.012).Subgroup analysis showed the same result in patients with paroxysmal af (paf) (p=0.039), but no difference was found in patients with persistent af (p=0.21).The average operation duration in the cba-2 group (85 (75¿99.5) min) was shorter than that in the rfca-ai group (100 (84.5¿120) min), but the average exposure time in the cba-2 group (17.36 (13.87¿22.49) min vs 5.49 (4.00¿8.24) min; p < 0.0001) and x-ray dose (223.25 (149.15¿336.95) min vs 109.15 (80.75¿168.7) min; p < 0.0001) were significantly longer than those in rfca-ai group.The patients were then divided into a late recurrent group and a late recurrence-free group.Multivariate logistic regression analysis showed that left atrial diameter (lad), early recurrence, and methods of ablation (cryoballoon ablation) were independent risk factors for late recurrence after af ablation.Conclusion: for patients with paf, cba-2 was inferior to rfca-ai.Furthermore, although rfca-ai had an equivalent complication rate and longer operation time than cba-2, it also had a shorter exposure time and required a lower radiation dose.The early recurrence of af and lad were independent risk factors for predicting late recurrence after af ablation.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: smarttouch sf catheter.Other biosense webster devices that were also used in this study: carto 3 system , lasso mapping catheter.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with biosense webster suspected device in rfca-ai group: qty 1 phrenic nerve palsy - (intervention not discussed).Qty 2 cardiac tamponade (intervention not discussed).Qty 1 pericardial effusion (intervention not discussed).Article reports all patients with complications were improved before discharge, and those with phrenic nerve palsy recovered.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16436924
• MDR Text Key: 310168283
• Report Number: 2029046-2023-00372
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 02/24/2023

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 Model Number: D134801
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/24/2023
• 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 3 SYSTEM; LASSO MAPPING CATHETER
• Patient Outcome(s): Life Threatening