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 Stroke/CVA (1770); Unspecified Nervous System Problem (4426)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: aoyama d, miyazaki s, amaya n, tama n, hasegawa k, nomura r, tsuji t, nakano a, uzui h, tada h.Treatment with catheter ablation for patients with arrhythmia-induced cardiomyopathy caused by atrial fibrillation promises a good prognosis.Heart vessels.2024 mar;39(3):240-251.Doi: 10.1007/s00380-023-02329-7.Epub 2023 oct 23.Pmid: 37872308.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 no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Manufacturer's ref # (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: aoyama d, miyazaki s, amaya n, tama n, hasegawa k, nomura r, tsuji t, nakano a, uzui h, tada h.Treatment with catheter ablation for patients with arrhythmia-induced cardiomyopathy caused by atrial fibrillation promises a good prognosis.Heart vessels.2024 mar;39(3):240-251.Doi: 10.1007/s00380-023-02329-7.Epub 2023 oct 23.Pmid: 37872308.Objective/methods/study data: clinical outcomes after catheter ablation in patients with reduced left ventricular (lv) ejection fraction (ef) and atrial fibrillation (af) remain unclear.This study aimed to explore the clinical outcomes of patients with arrhythmia-induced cardiomyopathy (aic) and the influence of pharmacological treatment on clinical outcomes in patients with aic after the procedure.Ninety-six patients with af with a reduced lvef (lvef < 50%, 66.7 ± 10.9 years; 72 males) underwent af ablation.Aic was defined as patients whose lvef recovered = 50% after catheter ablation (n = 67) and patients whose lvef remained reduced were defined as non-aic (n = 29).During a median follow-up of 25 (13-40) months, kaplan-meier analysis demonstrated that patients with aic were associated with less frequent cardiovascular death (p = 0.025) and hospitalization for worsening heart failure (p < 0.001) than those without aic.Freedom from af recurrence was similar between the two groups (p = 0.47).In multivariate analysis, the lv end-diastolic diameter (p = 0.0002) and the cha2ds2-vasc scores (p = 0.0062) were independent predictors of aic.Among the 67 patients with aic, no significant differences in baseline characteristics, except for lv chamber size and cryoballoon use, were observed between patients with aic with (n = 31) and without renin-angiotensin system (ras) inhibitors (n = 36).In the kaplan-meier analysis, cardiovascular death, hospitalization for worsening heart failure, and af recurrence after catheter ablation did not differ between patients treated with and without ras inhibitors (all p > 0.05).Catheter ablation in patients with aic due to af is associated with a good post-procedural prognosis.Irb information the study was approved by the research ethics committee of the university of fukui (no.(b)(6)) and clinical trial registration ((b)(6)).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf ablation catheter concomitant biosense webster devices that were used in this study: carto3 mapping system non-biosense webster devices that were also used in this study: arctic front cryoballoon (medtronic).Adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch sf ablation catheter: qty 2 transient gastric hypo-motility (neurologic impairment)(minor injury) qty 2 cerebral infarction (cerebrovascular accident)(recognized procedural complication).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref # (b)(4).It was previously reported on the 3500a initial report mwr-15032024-0001594514 as ¿qty 2 cerebral infarction (cerebrovascular accident)(recognized procedural complication)¿.The correct quantity is: ¿qty 1 cerebral infarction (cerebrovascular accident)(recognized procedural complication)¿.

• 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: 18924011
• MDR Text Key: 337904409
• Report Number: 2029046-2024-00880
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 03/20/2024
• 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: ARCTIC FRONT CRYOBALLOON (MEDTRONIC).; CARTO3 MAPPING SYSTEM.
• Patient Outcome(s): Life Threatening