BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_CELSIUS THERMOCOOL

    MDR report key: 8359136 · Received February 21, 2019

    Report

    Report Number
    2029046-2019-02716
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    December 31, 2017
    Report Date
    January 29, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: CARTO, LASSO. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ENSITE, COOLPATH DUO (ST. JUDE). MANUFACTURER'S REF. (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2019-02717 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: 1 PATIENT UNDERWENT INDEX CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED PSEUDOANEURYSM. 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 AND THERMOCOOL SMARTTOUCH. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO, LASSO. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ENSITE, COOLPATH DUO (ST. JUDE). PUBLICATION DETAILS: TITLE: IMPACT OF LEFT ATRIAL BOX SURFACE RATIO ON THE RECURRENCE AFTER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION. OBJECTIVE: TO EVALUATE THE INFLUENCE OF BOX LESION SURFACE AREA AS A RATIO OF TOTAL LA SURFACE AREA (BOX SURFACE RATIO) ON ARRHYTHMIA RECURRENCE. METHODS: BETWEEN 2013 AND 2017, 70 CONSECUTIVE PATIENTS WITH PERSISTENT AF (63±11 YEARS, 53 MEN) UNDERGOING COMPUTED TOMOGRAPHY (CT) IMAGING AND ABLATION PROCEDURE CONSISTING OF A FIRST BOX LESION WERE INCLUDED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150174 UNK_CELSIUS THERMOCOOL DRF LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention