BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ?

    MDR report key: 3850671 · Received June 5, 2014

    Report

    Report Number
    2134265-2014-03113
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    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

    AGE AT TIME OF EVENT: 18 YEARS AND OLDER. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SUSPENSION ARM DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 3.5-5.5 300CM FILTERWIRE EZ WAS SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION, THE DEVICE WAS REMOVED FROM THE PACKAGE AND AIR WAS EXPELLED. RESISTANCE WAS ENCOUNTERED UPON PULLING THE FILTER BAG INTO THE DELIVERY SHEATH AND IT WAS THEN NOTED THAT THE SUSPENSION ARM HAD DETACHED FROM THE PROTECTION WIRE SIDE AND THE REST OF THE ARM WAS STILL ATTACHED ON FILTER BAG SIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329685 FILTERWIRE EZ? TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE BOSTON SCIENTIFIC - SAN JOSE H749391423000 16608710

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: LAUNCHER 8FR