MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pseudoaneurysm (2605)

Event Date 04/30/2019

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's report numbers: 2029046-2021-00742 and 2029046-2021-00743.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 atrial fibrillation and suffered femoral pseudoaneurysm.Intervention was thrombin injection.Model and catalog number are not available, but the suspected device is navistar thermocool smarttouch.Other biosense webster devices that were also used in this study: lasso, carto 3 non-biosense webster devices that were also used in this study: 8.5-fr long sheaths(st judes).Publication details: title: costs and long-term outcomes following pulmonary vein isolation for atrial fibrillation in elderly patients using second-generation cryoballoon vs.Open-irrigated radiofrequency in china.Objective: limited comparative data are available regarding catheter ablation (ca) of atrial fibrillation (af) using secondgeneration cryoballoon (cb-2) vs.Radiofrequency (rf) ablation in elderly patients (> 75 years old.The present study aimed to compare the costs and clinical outcomes in elderly patients using these two strategies.Methods: elderly patients with symptomatic drug-refractory paroxysmal/short-lasting persistent af were included in the study.Pulmonary vein isolation (pvi) was performed in all patients.

• 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: 11803669
• MDR Text Key: 249975068
• Report Number: 2029046-2021-00741
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 04/21/2021
• 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: 8.5-FR LONG SHEATHS(ST JUDES); UNK_CARTO 3; UNK_LASSO
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR