BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM- 5.5MM)

    MDR report key: 1102090 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02233
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    May 6, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NFA
    PMA / PMN Number
    K032884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR FAILURE TO DEPLOY. DUE TO LOTS OF DRIED FLUID INSIDE THE DELIVERY SHEATH SHAFT ON THE RETURNED DEVICE, PROTECTION WIRE WAS STUCK INSIDE THE DELIVERY SHEATH AND SHEATHING/UNSHEATHING COULDN'T BE PERFORMED. ANALYSIS OF THE RETURNED DEVICE SHOWED THAT THE PROXIMAL END OF THE FLOPPY TIP WIRE WAS BROKEN AND DISTAL TIP OF DELIVERY SHEATH WAS DAMAGED. FOLLOW UP WITH THE CUSTOMER TO SEE IF RESISTANCE WAS FELT DURING REMOVAL OR ADVANCEMENT OF THE FILTERWIRE, AND IF THE FLOPPY TIPS WAS DAMAGED AFTER REMOVAL FROM THE PATIENT. CUSTOMER RESPOND THAT NO DIFFICULTY WAS FELT DURING ADVANCEMENT OR REMOVAL DURING PROCEDURE. THEY ONLY HAD DIFFICULTY TO REMOVAL THE DELIVERY SHEATH FOR DEPLOYMENT. THEY TRIED TO DEPLOY OUTSIDE OF THE PATIENT AND STILL HAD DIFFICULTY. ALSO THEY DIDN'T OBSERVE ANY DAMAGE ON THE FLOPPY TIP AFTER REMOVAL FROM THE PATIENT; THEREFORE THE DAMAGES ON THE FLOPPY TIP AND DISTAL TIP COULD POTENTIALLY BEEN CAUSED DURING HANDLING OF DEVICE POST PROCEDURE. ROOT CAUSE: DUE TO THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE MODE OF THE DEVICE CAN'T BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIALS, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF A FILTERWIRE EZ EMBOLIC SYSTEM, THE THE PHYSICIAN WAS UNABLE TO DEPLOY THE DEVICE. THIS COMPLAINT IS NOW REPORTABLE BASED ON ANALYSIS COMPLETED ON 07/17/2008. THE LESION BEING TREATED WAS A SAPHENOUS VEIN GRAFT TO THE CIRCUMFLEX. THE FILTERWIRE WAS PROPERLY PREPARED AND DELIVERED BUT COULD NOT DEPLOY. IT WAS REMOVED, A SECOND FILTERWIRE WAS PREPPED AND SUCCESSFULLY DEPLOYED. TWO STENTS WERE DELIVERED SUCCESSFULLY. THE SECOND FILTERWIRE WAS RETRIEVED AND CASE WAS A SUCCESS. THE PATIENT CONDITION WAS REPORTED AS O.K. AND THERE WERE NO COMPLICATIONS REPORTED. ANALYSIS WAS COMPLETED AND THE TIP OF THE WIRE WAS BROKEN AND DISTAL TIP OF DELIVERY SHEATH WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM- 5.5MM) NFA DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PR NFA BOSTON SCIENTIFIC CORPORATION 20100-190 0000734002

    Patients

    Seq Age Sex Outcome Treatment
    1