MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pericardial Effusion (3271)

Event Date 07/31/2019

Event Type  Death  

Manufacturer Narrative

Manufacturer's ref.No: pc (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.Patient codes - no information available.Multiple attempts have been made to obtain additional details regarding this event.However, no additional information has been made available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following manufacturer report numbers: 2029046-2020-01543, 2029046-2020-01544, 2029046-2020-01547.Are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent catheter ablation of ventricular arrhythmias and suffered death due to pulseless electrical activity arrest 1 day after the endocardial-epicardial ablation procedure.Postmortem examination showed a small circumferential pericardial effusion that did not explain the pulseless electrical activity arrest.Ice during and immediately after the ablation procedure had not shown any pericardial effusion.Model and catalog number are not available, but the suspected device is unk_navistar thermocool.Other biosense webster devices that were also used in this study: carto 3 system non-biosense webster devices that were also used in this study: agilis publication details title: ablation of ventricular arrhythmias from the left ventricular apex in patients without ischemic heart disease objective: this study aimed to characterize the incidence, clinical characteristics, and electrocardiographic and electrophysiologic features of lva va in the absence of cad and to describe the experience with catheter ablation (ca) in this group.Methods: patients referred for ca of va at our institution were retrospectively reviewed, and those with lva va in the absence of cad were identified.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• 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: 10737622
• MDR Text Key: 213151489
• Report Number: 2029046-2020-01545
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• 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): Death
• Patient Age: 54 YR