BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1920565 · Received December 13, 2010

    Report

    Report Number
    2134265-2010-05516
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DELIVERY SHEATH AND PROTECTION WIRE WERE RECEIVED COILED INSIDE A PLASTIC BAG. THE RETRIEVAL SHEATH WAS NOT RETURNED. DURING THE AS RECEIVED MICROSCOPE AND VISUAL INSPECTION OF THE RETURNED DEVICE, THE FILTER BAG WAS FULLY DEPLOYED FROM THE DELIVERY SHEATH. THE DISTAL TIP OF THE PROTECTION WIRE HAS A U-SHAPED BEND AND WAS STRETCHED APPROXIMATELY 2 MM ON ITS PROXIMAL PORTION. BY USING THE WIRE TORQUER, THE FILTER WAS INSERTED BACK INTO THE DELIVERY SHEATH AND THEN UNSHEATHED (DEPLOYED) WITH NO DIFFICULTY. 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 PRIOR TO PATIENT CONTACT. (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 PRIOR TO A CAROTID ARTERY TREATMENT PROCEDURE THE FILTERWIRE WAS DAMAGED. THE LESION BEING TREATED WAS LOCATED IN LEFT CAROTID ARTERY THAT WAS 9.0MM, 20MM LONG AND 80% STENOSED. PRIOR TO USE, THE PHYSICIAN WAS SHAPING THE SPRING COIL TIP OF THE PROTECTION WIRE WHEN IT BECAME "DISLODGED". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A CAROTID ARTERY TREATMENT PROCEDURE THE FILTERWIRE WAS DAMAGED. THE LESION BEING TREATED WAS LOCATED IN LEFT CAROTID ARTERY THAT WAS 9.0MM, 20MM LONG AND 80% STENOSED. PRIOR TO USE, THE PHYSICIAN WAS SHAPING THE SPRING COIL TIP OF THE PROTECTION WIRE WHEN IT BECAME "DISLODGED". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT CONDITION 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 0000925206

    Patients

    Seq Age Sex Outcome Treatment
    1