BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELSIUS THERMO-COOL DIAGNOSTIC ABLATION DEFLECTABLE TIP CATH

    MDR report key: 625576 · Received August 11, 2005

    Report

    Report Number
    2029046-2005-00090
    Event Type
    Other
    Date Received
    August 11, 2005
    Date of Event
    February 2, 2005
    Report Date
    February 4, 2005
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ATRIAL FLUTTER PROCEDURE WITH CELSIUS THERMOCOOL, PHYSICIAN NOTICED A "POP" AFTER THE 4TH ABLATION. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELSIUS THERMO-COOL DIAGNOSTIC ABLATION DEFLECTABLE TIP CATH DIAGNOSTIC DEFLECTABLE TIP CATHETER LPB BIOSENSE WEBSTER, INC. D-1189-02-S 13018384

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO