BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTER WIRE EZ

    MDR report key: 1151663 · Received September 4, 2008

    Report

    Report Number
    1151663
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING CARDIAC CATHETERIZATION. THE DISTAL END OF THE FILTER WIRE RETRIEVAL SHEATH BROKE OFF INSIDE PATIENT WHILE STILL ON FILER WIRE. VASCULAR SPECIALIST CONSULTED IMMEDIATELY AND HE SNARED THE RETRIEVAL SHEATH AND FILTER WIRE AND REMOVED THEM FROM THE PATIENT WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTER WIRE EZ RETRIEVAL SHEATH NFA BOSTON SCIENTIFIC REF. # 20100-190 0816104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other