BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR CONSOLE UNIT

    MDR report key: 1062049 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00722
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE THAT OCCURRED IN 2008. AFTER SUCCESSFUL COMPLETING OF THE ABLATION CYCLE, THE HTA UNIT DISPLAY REMAINED AT THE ABLATION TEMP OF 90 DEGREES; THE DISPLAY REMAINED AT THIS TEMP FOR APPROXIMATELY 25 MINUTES. THE UNIT WAS SUBSEQUENTLY TESTED BY THE NURSE WITH A NEW HEATER CANISTER & PROCEDURE PACK & IT REPEATED THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR CONSOLE UNIT MNB BOSTON SCIENTIFIC CORPORATION M00656001DM0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK