BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHILLI II

    MDR report key: 1003925 · Received November 6, 2007

    Report

    Report Number
    1003925
    Event Type
    Malfunction
    Date Received
    November 6, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 5, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR PASSED THE CHILLI II CRYOTHERAPY ABLATION CATHETER THROUGH AN 8.5 FRENCH SHEATH AND POSITIONED IT FOR THE ABLATION PROCEDURE. HOWEVER, THE PHYSICIAN WAS UNABLE TO GET THE DEVICE TO BEND AS IT IS DESIGNED TO DO. PER THE STAFF AND THE PHYSICIAN, THE DIRECTIONAL CONTROL/COMPONENT OF THE DEVICE WAS NOT WORKING. THE DOCTOR REMOVED THE CATHETER AND USED ANOTHER DEVICE WITH THE SAME MAKE AND MODEL TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. NO VISUAL DEFECTS COULD BE IDENTIFIED ON THE DEVICE IN QUESTION. THERE WAS NO PATIENT HARM AS A RESULT OF THIS INCIDENT. THE BOSTON SCIENTIFIC REPRESENTATIVE WAS NOTIFIED OF THE EVENT BY THE CATH LAB STAFF, AND THE FOLLOWING DAY THE RISK MANAGEMENT DEPARTMENT ALSO SPOKE WITH THE SAME REP. REGARDING THIS FAILURE. THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILLI II CATHETER, ABLATION, CRYOTHERAPY GEH BOSTON SCIENTIFIC M00490310 9788662

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR CARDIAC DRUGS| CARDIAC DRUGS