BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1963054 · Received January 18, 2011

    Report

    Report Number
    2134265-2010-05946
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETRIEVAL SHEATH AND PROTECTION WIRE WERE RECEIVED COILED INSIDE A PLASTIC BAG. THE FILTER BAG WAS RETRACTED FULLY INTO THE RETRIEVAL SHEATH WITH 4 MM OF THE NOSECONE EXPOSED OUT OF THE DISTAL TIP OF THE RETRIEVAL SHEATH. THE DISTAL TIP OF THE PROTECTION WIRE WAS BENT, CURLY AND WAS STRETCHED APPROXIMATELY 5 MM, MEASURED FROM THE PROXIMAL SIDE OF THE COIL. USING THE WIRE TORQUER, WAS ABLE TO PERFORM SHEATHING / UNSHEATHING TESTS WITH NO DIFFICULTY. THERE WAS NO BLOOD PARTICULATE INSIDE OF THE FILTER BAG. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A VESSEL SPASM. THE TARGET LESION BEING TREATED WAS LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. WHILE ATTEMPTING TO PLACE THE UNKNOWN SIZE CAROTID WALLSTENT IN LESION, IT WAS NOTED THAT THERE WERE CONTINUOUS MOVEMENT OF THE FILTERWIRE EZ. DUE TO THIS, THE PATIENT EXPERIENCED A VESSEL SPASM. THE DEVICE WAS EXCHANGED AND A NON-BSC DEVICE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A VESSEL SPASM. THE TARGET LESION BEING TREATED WAS LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. WHILE ATTEMPTING TO PLACE THE UNKNOWN SIZE CAROTID WALLSTENT IN LESION, IT WAS NOTED THAT THERE WERE CONTINUOUS MOVEMENT OF THE FILTERWIRE EZ. DUE TO THIS, THE PATIENT EXPERIENCED A VESSEL SPASM. THE DEVICE WAS EXCHANGED AND A NON-BSC DEVICE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201051900 13409923

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CAROTID WALLSTENT