BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ¿

    MDR report key: 2833002 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06813
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NTE
    PMA / PMN Number
    K063313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE PROTECTION WIRE AND THE RETRIEVAL SHEATH WERE RETURNED HAND COILED. THE DELIVERY SHEATH WAS NOT RETURNED. DURING THE VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE, THE RADIOPAQUE DISTAL TIP OF THE PROTECTION WIRE WAS FOUND CURVED, WAVY, AND HAD BEEN STRETCHED APPROXIMATELY 4 MM ON ITS PROXIMAL PORTION. THE FILTER BAG WAS FOUND RETRACTED INTO THE RETRIEVAL SHEATH WITH 8 MM OF THE NOSECONE EXPOSED FROM THE DISTAL TIP OF THE RETRIEVAL SHEATH. BLOOD WAS FOUND ON THE INSIDE AND OUTSIDE OF THE RETRIEVAL SHEATH. THE WIRE TORQUER WAS FOUND ATTACHED TO THE PROTECTION WIRE AT 117.4 CM, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE COREWIRE WAS FOUND SLIGHTLY CURVED. THE PROTECTION WIRE WAS ABLE TO BE MOVED BACK AND FORTH INSIDE THE SHEATH. IT WAS NOT STUCK. THE FILTER BAG WAS DEPLOYED, AND UPON INSPECTION WAS FOUND TO BE IN GOOD CONDITION. HOWEVER, THE TIP SEAL BOND OF THE FILTER BAG WAS BROKEN FROM THE COIL STOP TUBE - ALLOWING THE FILTER BAG TO MOVE UP AND DOWN THE TUBE. THE COMPONENT WAS NOT DETACHED FROM THE DEVICE. ADHESIVE WAS FOUND IN THE CORRECT LOCATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING PROCEDURE, FILTER BAG BOND ISSUES OCCURRED. THE TARGET LESION WAS A RIGHT INTERNAL CAROTID ARTERY. A FILTERWIRE EZ 3.5-5.5 190CM PV-JP WAS USED TO TREAT THE TARGET LESION. THE FILTERWIRE WAS REMOVED INTACT. POST THE PROCEDURE IT WAS NOTED THAT THE FILTER BAG WAS "NOT BONDED PROPERLY," NO BREAKS OR FILTER DETACHMENT WAS NOTED ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING PROCEDURE, FILTER BAG BOND ISSUES OCCURRED. THE TARGET LESION WAS A RIGHT INTERNAL CAROTID ARTERY. A FILTERWIRE EZ 3.5-5.5 190 CM PV-JP WAS USED TO TREAT THE TARGET LESION. THE FILTERWIRE WAS REMOVED INTACT. POST THE PROCEDURE IT WAS NOTED THAT THE FILTER BAG WAS "NOT BONDED PROPERLY," NO BREAKS OR FILTER DETACHMENT WAS NOTED ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ¿ TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE BOSTON SCIENTIFIC - SAN JOSE H749391421900 15458407

    Patients

    Seq Age Sex Outcome Treatment
    1