BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ¿

    MDR report key: 2170573 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02970
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    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 MFR: DURING VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE, THE DISTAL TIP OF THE PROTECTION WIRE WAS FOUND NORMAL AND IN GOOD CONDITION. THE FILTER BAG WAS FOUND PARTIALLY RETRACTED INTO THE DELIVERY SHEATH WITH 11MM OF THE NOSECONE EXPOSED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. 1.5 MM OF THE FILTER BAG WAS FOUND EXPOSED OUT OF THE DISTAL TIP OF THE DELIVERY SHEATH. DURING CLOSE VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE FILTER BAG, NO UNUSUAL OR LOOSE/FOREIGN MATERIAL WAS FOUND INSIDE THE FILTER BAG. THE FILTER BAG WAS FOUND IN NORMAL AND IN GOOD CONDITION. THE WIRE TORQUER WAS FOUND ATTACHED TO THE PROTECTION WIRE AT 133.5 CM, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE AND DRIED BLOOD WAS FOUND ON THE OUTSIDE OF THE WIRE TORQUER. USING THE SAME WIRE TORQUER WAS ABLE TO PERFORM SHEATHING/ UNSHEATHING TEST WITH NO DIFFICULTY. THERE WERE NO ISSUES FOUND DURING VISUAL AND MICROSCOPIC INSPECTION OF THE PROTECTION WIRE, THE FILTER BAG AND THE DELIVERY SHEATH. 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 CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A STENTING TREATMENT PROCEDURE, FOREIGN MATERIAL WAS NOTED. THE FOREIGN MATTER WAS NOTED IN THE FILTER WIRE EZ 3.5-5.5 190CM. THIS OCCURRED OUTSIDE OF THE BODY WITH NO PATIENT CONTACT. THIS PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A STENTING TREATMENT PROCEDURE, FOREIGN MATERIAL WAS NOTED. THE FOREIGN MATTER WAS NOTED IN THE FILTER WIRE EZ 3.5-5.5 190CM. THIS OCCURRED OUTSIDE OF THE BODY WITH NO PATIENT CONTACT. THIS PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS 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 14308578

    Patients

    Seq Age Sex Outcome Treatment
    1