MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No : (b)(4).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.Biosense webster manufacturer's report numbers: 2029046-2021-00815, and 2029046-2021-00816.Are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: these patients were categorized into two groups: improve group (i group) with the absolute improvement of lvef=10% at follow-up tte, and non- improve group (ni group) with the absolute improvement of lvef.It was reported that 1 patient in group i underwent catheter ablation of atrial fibrillation and suffered cardiac tamponade.Intervention was not reported.Model and catalog number are not available, but the suspected device is thermocool smarttouch.Other biosense webster devices that were also used in this study: carto 3 non-biosense webster devices that were also used in this study: beeat, 8.5 fr sl0 publication details title: predictors of improvement of left ventricular systolic function after catheter ablation of persistent atrial fibrillation in patients with heart failure with reduced ejection fraction.Objective: although several studies have suggested that catheter ablation (ca) of atrial fibrillation (af) can improve left ventricular ejection fraction (lvef) in patients with heart failure with reduced ejection fraction (hfref), the predictor of improvement of lvef is unclear.Methods: a total of 401 patients with persistent af underwent an initial ca between (b)(6) 2014 and (b)(6) 2019 in our hospital.Among them, we analyzed consecutive patients with moderately or severely reduced lvef (< 50%) measured by transthoracic echocardiography (tte) within 2 months before ca and underwent follow-up tte during sinus rhythm at 6 months or more after ca.These patients were categorized into two groups: improve group (i group) with the absolute improvement of lvef = 10% at follow-up tte, and non- improve group (ni group) with the absolute improvement of lvef < 10% at follow-up tte.We compared patient characteristics, ablation procedures, and clinical outcomes between the two groups.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 11882651
• MDR Text Key: 256445358
• Report Number: 2029046-2021-00814
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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: 05/03/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR