BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ?

    MDR report key: 3932406 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04090
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NTE
    PMA / PMN Number
    K063313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. THE RETRIEVAL SHEATH AND THE PROTECTION WIRE WERE RETURNED INSIDE A PLASTIC BAG WITH THE JACKAL RX GUIDE WIRE. ALL WERE PACKED INSIDE A DOUBLE PLASTIC BAG. 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 6 MM ON ITS PROXIMAL PORTION. THE FILTER BAG WAS FOUND DEPLOYED. APPROXIMATELY 4 MM OF THE DISTAL END OF THE FILTER BAG WAS FOUND MISSING AND RIPPED OFF. THE RIPPED EDGES APPEAR UNEVEN AND JAGGED. BLOOD WAS FOUND ON THE INSIDE OF THE RETRIEVAL SHEATH. THE WIRE WAS FOUND KINKED APPROXIMATELY AT 121 CM, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE WIRE TORQUER WAS FOUND ATTACHED TO THE PROTECTION WIRE AT 122 CM, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FILTERWIRE BAG WAS TORN. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. DURING PROCEDURE, THE 3.5-5.5 190CM FILTERWIRE EZ¿ CATHETER WAS PASSED THROUGH AN IMPLANTED CAROTID WALLSTENT. UPON RETRIEVAL, STRONG RESISTANCE WAS ENCOUNTERED WHEN THE FILTERWIRE WENT THROUGH THE DISTAL EDGE OF THE STENT. THEY WERE ABLE TO REMOVE THIS DEVICE FROM THE PATIENT WITHOUT SURGERY AND IT WAS THEN NOTED THAT THE DISTAL OF THE FILTER BAG WAS TORN. NO ATTEMPT WAS MADE TO RETRIEVE THE FILTER BAG AS IF WAS DECIDED TO USE A "WAIT AND SEE" APPROACH. DURING A MAGNETIC RESONANCE IMAGING(MRI), IT WAS NOTED THAT THE DETACHED FILTER BAG REMAINED AT THE DISTAL END OF THE MIDDLE CEREBRAL ARTERY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411348 FILTERWIRE EZ? TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE BOSTON SCIENTIFIC - SAN JOSE H749391421900 16828464

    Patients

    Seq Age Sex Outcome Treatment
    1 Other STENT: CAROID WALLSTENT| GUIDING CATHETER: 8FR OPTIMO