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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: bai xueyang , bai zhongle, liu gangqiong, wang jin, hong jin, li ling, dong jianzeng.Clinical application of zero-ray atrial fibrillation radiofrequency ablation guided by simple intracardiac ultrasound.Chinese journal of evidence-based cardiovascular medicine, may 2021, vol.13, no.5 chin j evid based cardiovasc med, may, 2021, vol.13, no.5 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: bai xueyang , bai zhongle, liu gangqiong, wang jin, hong jin, li ling, dong jianzeng.Clinical application of zero-ray atrial fibrillation radiofrequency ablation guided by simple intracardiac ultrasound.Chinese journal of evidence-based cardiovascular medicine, may 2021, vol.13, no.5 chin j evid based cardiovasc med, may, 2021, vol.13, no.5.Objective/methods/study data: -objective to discuss the effectiveness and safety of zero-x ray radiofrequency catheter ablation (rfca) guided by a simple method of intracardiac echocardiography for atrial fibrillation (af).-methods af patients (n = 120) received planed rfca chosen from the first affiliated hospital of zhengzhou university from apr.2020 to oct.2020.All patients were divided into control group rfca with routine method, and test group undergone zero-x ray rfca with simple method of intracardiac echocardiography (each n = 60).The placement time of coronary sinus electrode, time of atrial septal puncture, time of left atrial modeling, the total time of preconditioning, time of x-ray exposure and incidence of complications were compared between 2 groups.Results the time of atrial septal puncture was longer a little (p < 0.001), and time of left atrial modeling was shorter (p < 0.001) in the test group than those in the control group.The difference in the total time of preconditioning had no statistical significance between 2 groups (p > 0.05).The time of x-ray exposure was 0 in test group.Conclusion zero-x ray exposure can be realized in rfca guided by a simple method of intracardiac echocardiography for af, which is safe and effective.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smart touch nav, johnson & johnson, usa.Other biosense webster concomitant devices that were also used in this study: carto3 electroanatomic mapping system (v6, johnson & johnson, usa).Soundstar, johnson & johnson, usa -deca nav, johnson & johnson, usa).Pentaray nav, johnson & johnson, usa).Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: two adverse events were reported in this literature source: during ablation, there was one case of cardiac tamponade with pericardiocentesis drainage in the control group.There was 1 case of small amount of pericardial effusion in the test group, without special treatment.There was no mention of further interventions provided.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14912471
• MDR Text Key: 295226313
• Report Number: 2029046-2022-01505
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO3 ELECTROANATOMIC MAPPING SYSTEM V6; PENTARAY NAV; SOUNDSTAR
• Patient Outcome(s): Life Threatening