BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 717554 · Received November 16, 2005

    Report

    Report Number
    3004742046-2005-00398
    Event Type
    Malfunction
    Date Received
    November 16, 2005
    Date of Event
    October 17, 2005
    Report Date
    October 17, 2005
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    FGE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABSOLUTE WAS USED AND DURING PREPARATION BECAME STUCK ON THE GUIDE WIRE. WHEN TRYING TO REMOVE THE UNIT FROM THE GUIDE WIRE, FORCE WAS USED AND THE TIP OF HE ABSOLUTE SEPARATED OUTSIDE OF HE PATIENT'S BODY. THE GUIDE WIRE WAS WIPE DOWN AGAIN AND A NEW DEVICE WAS USED WITHOUT INCIDENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE GUIDANT ENDOVASCULAR SOLUTIONS NA 5082451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN