MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR

Catalog Number UNK_NAVISTAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/05/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report numbers: 2029046-2021-00664, 2029046-2021-00665, 2029046-2021-00667, 2029046-2021-00668, 2029046-2021-00669, and 2029046-2021-00670 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: group 1 ( less than or equal to 2 pulmonary vein isolations ).It was reported that 2 patients from the group undergoing less than or equal to 2 pulmonary vein isolations underwent catheter ablation of atrial fibrillation and suffered pericardial effusion requiring drainage.Model and catalog number are not available, but the suspected device is navi-star.Other biosense webster devices that were also used in this study: 10-pole lasso non-biosense webster devices that were also used in this study: chilli, acunav.Publication details: title: predictors of success after selective pulmonary vein isolation of arrhythmogenic pulmonary veins for treatment of atrial fibrillation.Objective: the purpose of this study was to identify a subgroup of patients undergoing af ablation with good clinical success after limited pv isolation.Methods: patients (n= 450) underwent trigger-guided segmental isolation of only arrhythmogenic pvs.We compared clinical characteristics of patients who required isolation of only one or two pvs to those in whom af ablation required isolating greater then/equal to 3 pvs.

• Brand Name: UNK_NAVISTAR
• Type of Device: UNK
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 11729973
• MDR Text Key: 247477475
• Report Number: 2029046-2021-00666
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2021

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_NAVISTAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/26/2021
• 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
• Treatment: ACUNAV; CHILLI; UNK_LASSO
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR