BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2588419 · Received May 18, 2012

    Report

    Report Number
    MW5025483
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 18, 2012
    Report Date
    May 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GEMESYS HTA PROCEDURE SHEATH CAME APART DURING ABLATION, HOT NACL LEAKED OUT AND THE PROCEDURE WAS STOPPED. SIX MINUTES OUT OF 8 COMPLETED. NO HOT NACL TOUCHED PATIENT OR STAFF. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC GENESYS HTA PROCERVA PROCEDURE SET MNB BOSTON SCIENTIFIC M006580210 801091342879

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR