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

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Edema (2020); Pericardial Effusion (3271)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: shushan zhang.Zhang yanhe.Chang dong.Yan zong yang.Catheter ablation for atrial tachyarrhythmia; observation of long-term prognosis of fast and slow syndrome.Chinese journal of cardiac pacing and electrophysiology 2020 year no.34 volume no.4 period.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.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.Note: field d4.Catalog should reflect as unk_smart touch bidirectional sf.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: shushan zhang.Zhang yanhe.Chang dong.Yan zong yang.Catheter ablation for atrial tachyarrhythmia; observation of long-term prognosis of fast and slow syndrome.Chinese journal of cardiac pacing and electrophysiology 2020 year no.34 volume no.4 period.Objective/methods/study data: objective: catheter ablation has been used for the treatment of tachycardia-bradycardia syndrome (tbs.However, data on its long-term effect of rhythm control and stroke are limited.Method: patients with tbs admitted in the first affiliated hospital of dalian medical university from 2002-2013 were reviewed in the present study.A total of 150 patients were enrolled.Seventy-nine patients underwent catheter ablation (ca group) and 71 patients chose implantation of pacemaker (pm group.Results : two groups were followed up.The ca group underwent 1 2.± 0 5.Procedure.Of these, 70.9% patients exhibited sinus rhythm without long pauses or the need of anti-arrhythmia drugs.By contrast ,no patient in pm group was free of atrial fibrillation (af).A higher proportion in pm group progressed to persistent af than in ca group.The incidence of new-onset stroke in pm group was significantly higher than that in ca group, despite higher rates of anticoagulation prescription ( there was no mention of when strokes were noted within the 10 year follow up period).Conclusions catheter ablation is effective for preventing both the tachycardia and bradycardia components for the majority of patients with tbs without the need for further pacemaker implantation.Moreover, ablation can reduce the stroke incidence of tbs.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: salt water-perfused catheter, johnson & johnson, usa used with ep shuttle.For reportability purposes this will be coded under unk_smart touch bidirectional sf.Other biosense webster concomitant devices that were also used in this study: 4 pole electrode was placed (johnson & johnson).Lasso electrode, johnson & johnson company, usa).Carto, johnson & johnson, usa).Ep shuttle, johnson & johnson, usa).Non-biosense webster concomitant devices that were also used in this study: 10 pole electrode (st.Jude medical, usa).Long sheath (san jude company, china).Adverse event(s) and provided interventions: 1 case of pericardial effusion.1 case of pulmonary edema.There was no mention of 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: 15161713
• MDR Text Key: 297210078
• Report Number: 2029046-2022-01781
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• 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: 10 POLE ELECTRODE (ST. JUDE MEDICAL, USA); 4-POLE ELECTRODE WAS PLACED (JOHNSON & JOHNSON); EP SHUTTLE, JOHNSON & JOHNSON, USA); LONG SHEATH (SAN JUDE COMPANY, CHINA); UNK_CARTO 3; UNK_LASSO
• Patient Outcome(s): Other