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 Problem Transient Ischemic Attack (2109)

Event Date 12/31/2010

Event Type  Injury  

Manufacturer Narrative

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.Concomitant products that used in this study: lasso.Non-biosense webster devices that were also used in this study: none manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2019-02564, 2029046-2019-02565 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication (for simplicity, if only thrombolytic event was mentioned it is viewed as stroke: 8 patients (2 group 1 and 6 in group 2) underwent catheter ablation of atrial fibrillation and suffered a transient ischemic attack.No further details were provided.Multiple requests for clarification have been sent to the corresponding author, but no additional details were provided at this time.If additional details will be provided this report will be updated accordingly.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is thermocool other biosense webster devices that were also used in this study: lasso non-biosense webster devices that were also used in this study: none publication details: title: impact of dense "smoke" detected on transesophageal echocardiography on stroke risk in patients with atrial fibrillation undergoing catheter ablation.Objective: the purpose of this study was to evaluate the risk of te events in the periprocedural period and at long-term follow-up in atrial fibrillation (af) patients having dense smoke on preprocedural tee.Methods: a total of 2511 patients undergoing af ablation (2009-2010) were included in this analysis.They were classified as group 1 (dense smoke detected on tee at baseline; n = 234) and group 2 (no smoke on baseline tee; n = 2277).Patients were followed up for te events, which included both stroke and transient ischemic attacks (tias).In order to attenuate the observed imbalance in baseline covariates between the study groups, a propensity score matching technique was used (covariates were age, sex, af type, diabetes, and chads2vasc score).

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: UNK_NAVISTAR THERMOCOOL
• 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8251327
• MDR Text Key: 133241351
• Report Number: 2029046-2019-02564
• Device Sequence Number: 1
• Product Code: LPB
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• 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: 12/26/2018
• 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): Other
• Patient Age: 65 YR