MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: özveren o, mutluer fo, tutuncu a, tenekecioglu e, kanat s, aksu t.Successful radiofrequency catheter ablation of idiopathic premature ventricular complexes originating from the outflow tract improves heart failure-related quality of life.J interv card electrophysiol.2022 jun 22.Doi: 10.1007/s10840-022-01264-3.Epub ahead of print.Pmid: 35731329.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 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.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: özveren o, mutluer fo, tutuncu a, tenekecioglu e, kanat s, aksu t.Successful radiofrequency catheter ablation of idiopathic premature ventricular complexes originating from the outflow tract improves heart failure-related quality of life.J interv card electrophysiol.2022 jun 22.Doi: 10.1007/s10840-022-01264-3.Epub ahead of print.Pmid: 35731329.Objective/methods/study data: authors aim to investigate if following successful rfca of ot-pvcs results in improvement in lv and la function assessed by transthoracic echocardiography (tte), attenuation in neurohormonal activation determined by serum n-terminal pro brain natriuretic (nt-probnp) levels, and functional improvement assessed quantitatively by 6-min walking distance (6mwd) test and qualitatively by nyha class.Consequently, improvement in hf-qol evaluated with the use of minnesota living with heart failure questionnaire (mlhfq) was investigated.Patients older than 18 years who underwent successful b20rfca of ot-pvcs between january 2015 and april 2018 were prospectively enrolled in this study.Patients who had ot-pvcs based on 12 lead ecg and satisfied at least one of the following conditions, who underwent rfca and satisfied the ¿acute success¿ definition, were enrolled in this study: (1) patients with a ¿high¿ pvc burden of>10% of the total number of beats in the 24-h holter ecg recording; (2) patients with symptomatic pic, defined as a lv ejection fraction (lvef) of<50% unattributable to alternative causes.A total 108 of 117 patients undergoing successful ablation with a mean age of 43±12 years and 60 male patients (56%) were enrolled in the study.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch cf for mapping and for rfca 9 radiofrequency catheter ablation) other biosense webster devices that were also used in this study: carto concomitant non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions: qty 4 minor bleeding - treated with conservative management of fluid resuscitation and erythrocyte suspension transfusion.Qty 1 cerebrovascular accident (cva) - outcome of slurred speech shortly after procedure finished, treated with anticoagulation with a non-vitamin k oral medication with resultant partial recovery during hospital stay and complete recovery at 6 months.Qty 4 pericardial effusion - three of these resolved with conservative outpatient management while the remaining one required pericardiocentesis due to tamponade and uneventfully discharged.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15298617
• MDR Text Key: 298666325
• Report Number: 2029046-2022-01983
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 08/25/2022

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_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/25/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention