BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ¿

    MDR report key: 2830310 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-06886
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 2012
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED THE DELIVERY AND RETRIEVAL SHEATHS WERE NOT RETURNED. THE PROTECTION WIRE WAS RETURNED INSIDE THE PACKAGING COIL. THE PROTECTION WIRE WAS FOUND SEPARATED INTO 2 PIECES. THE DISTAL PORTION OF THE PROTECTION WIRE MEASURED ABOUT 31.4CM IN LENGTH. THE PROXIMAL END PIECE MEASURED ABOUT 155CM TOTAL IN LENGTH. THERE WERE BENDS AT THE BROKEN ENDS ON BOTH PIECES OF THE RETURNED DEVICE. THE DISTAL TIP WAS SLIGHTLY CURVED. THE DISTAL PORTION WAS KINKED APPROXIMATELY 27.4CM FROM THE DISTAL TIP. THE PROXIMAL PORTION WAS KINKED 92CM FROM THE PROXIMAL END. THE FILTER BAG WAS OBSERVED TO BE IN GOOD CONDITION AND MET SPECIFICATIONS, NO ANOMALIES WERE OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE DFU STATES: "DO NOT PULL EXCESSIVELY ON THE PROTECTION WIRE OR THE EZ RETRIEVAL SHEATH TO AVOID TEARING THE FILTER MEMBRANE, FILTER LOOP DETACHMENT OR OTHER PROTECTION WIRE DAMAGE. GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A WIRE BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED ON THE PATIENT'S RIGHT SIDE VIA AN UNSPECIFIED SITE. THE 80 X 7-9.0 MM, DE NOVO, 80% STENOSED AND ECCENTRICALLY SHAPED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT INTERNAL CAROTID ARTERY. PREDILATION WAS NOT PERFORMED. THE FILTERWIRE EZ WAS ADVANCED AND POSITIONED IN THE PATIENT. TWO STENTS, A 7.0 X 30 MM AND A 9.0 X 40 MM, WERE DEPLOYED IN THE CAROTID ARTERY AND A 5.5 X 20 MM STERLING BALLOON CATHETER WAS UTILIZED FOR POST-DILATION. AFTER INFLATION, AT AN UNSPECIFIED TIME DURING POST-DILATION, IT WAS NOTED THAT THE FILTERWIRE EZ HAD BROKEN INTO TWO PIECES, 20 CM FROM THE TIP OF THE DEVICE. THE DEVICE WAS COMPLETELY REMOVED WITH THE 7FR KIMNY GUIDE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FILTERWIRE EZ. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A WIRE BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED ON THE PATIENT'S RIGHT SIDE VIA AN UNSPECIFIED SITE. THE 80X7-9.0MM, DE NOVO, 80% STENOSED AND ECCENTRICALLY SHAPED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT INTERNAL CAROTID ARTERY. PREDILATION WAS NOT PERFORMED. THE FILTERWIRE EZ WAS ADVANCED AND POSITIONED IN THE PATIENT. TWO STENTS, A 7.0X30MM AND A 9.0X40MM, WERE DEPLOYED IN THE CAROTID ARTERY AND A 5.5X20MM STERLING BALLOON CATHETER WAS UTILIZED FOR POST-DILATION. AFTER INFLATION, AT AN UNSPECIFIED TIME DURING POST-DILATION, IT WAS NOTED THAT THE FILTERWIRE EZ HAD BROKEN INTO TWO PIECES, 20CM FROM THE TIP OF THE DEVICE. THE DEVICE WAS COMPLETELY REMOVED WITH THE 7FR KIMNY GUIDE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FILTERWIRE EZ. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ¿ TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201051900 15112224

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 5.5 X 20 MM STERLING BALLOON CATHETER