BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ¿

    MDR report key: 3111405 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03165
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: OVER (B)(6). (B)(4). DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THE DELIVERY SHEATH WAS NOT RETURNED. VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED THE RADIOPAQUE DISTAL TIP OF THE PROTECTION WIRE WAS FOUND CURVED, SLIGHTLY WAVY AND HAD BEEN STRETCHED APPROXIMATELY 3 MM ON ITS PROXIMAL PORTION. THE FILTER BAG WAS FOUND DEPLOYED. APPROXIMATELY 6 MM OF THE DISTAL END OF THE FILTER BAG WAS FOUND MISSING AND RIPPED OFF. THE RIPPED EDGES APPEARED UNEVEN AND JAGGED. BLOOD WAS FOUND ON THE INSIDE OF THE RETRIEVAL SHEATH AND INSIDE THE FILTER BAG. THE WIRE WAS FOUND KINKED APPROXIMATELY AT 85.7 CM AND 86.3 CM, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE PROXIMAL END OF PROTECTION WIRE WAS FOUND WAVY AND CURVED. THE SHEATH WAS FOUND KINKED AT 142 CM AT COREWIRE WHEN MEASURED FROM THE DISTAL TIP OF THE RETRIEVAL SHEATH. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATHERECTOMY INTERVENTION PROCEDURE, A FILTERWIRE BROKE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 300 CM FILTERWIRE EZ ENCOUNTERED NO DIFFICULTY CROSSING OR PASSING THE TARGET LESION, AND THE FILTER WAS SUCCESSFULLY DEPLOYED. UPON COMPLETION OF TREATMENT, DURING RETRIEVAL OF THE FILTER, NO DIFFICULTY WAS ENCOUNTERED DURING PULL BACK, BUT WHEN THE FILTER WAS PULLED INTO THE 7F NON BSC SHEATH THE FILTER DETACHED AND REMAINED INSIDE THE SHEATH. THE DETACHED FILTER WAS REMOVED TOGETHER WITH THE WITHDRAWAL OF THE INTRODUCER SHEATH. THE PROCEDURE HAD BEEN COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213306 FILTERWIRE EZ¿ TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201003000 15706179

    Patients

    Seq Age Sex Outcome Treatment
    1