BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_NAVISTAR THERMOCOOL

    MDR report key: 11803657 · Received May 10, 2021

    Report

    Report Number
    2029046-2021-00742
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 30, 2019
    Report Date
    April 21, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: 2029046-2021-00741 AND 2029046-2021-00743. ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 2 PATIENTS UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED CARDIAC TAMPONADE. INTERVENTION WAS PERICARDIOCENTESIS. 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 (B)(6). 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694965 UNK_NAVISTAR THERMOCOOL UNK OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening 8.5-FR LONG SHEATHS(ST JUDES)| UNK_CARTO 3| UNK_LASSO