BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ¿

    MDR report key: 2830273 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-07119
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER CORRECTED FROM 15146491 TO 0015023843. DEVICE EXPIRATION DATE CORRECTED FROM 02-APR-2014 TO 09-FEB-2014. DEVICE MANUFACTURED DATE CORRECTED FROM 03-APR-2012 TO 14-FEB-2012. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED DEVICE REVEALED THE RADIOPAQUE DISTAL TIP OF THE PROTECTION WIRE WAS CURVED. IT WAS NOT WAVY, STRETCHED OR DAMAGED. THE FILTER BAG WAS FOUND PARTIALLY DEPLOYED WITH 1 CM OF THE FILTER EXPOSED. BLOOD WAS FOUND ON THE INSIDE OF THE DELIVERY SHEATH AND ON THE INSIDE THE FILTER BAG. THE WIRE WAS FOUND SEVERELY CURVED AND KINKED AT APPROXIMATELY 11.6 CM (KINKED), 12.8 CM (CURVED), 13.5 CM (KINKED), 20 CM (CURVED), 25 CM (CURVED) AND 26.1 CM (KINKED), WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE WIRE TORQUER WAS FOUND ATTACHED TO THE PROTECTION WIRE AT 97 CM, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE PROTECTION WIRE WAS FOUND EXPOSED (FOUND POPPED OUT) OUT OF THE SLIT IN THE DELIVERY SHEATH FROM 6.5 CM TO 28 CM, AND THEN AGAIN AT 47 CM THROUGH THE ENTIRE SHEATH, WHEN MEASURED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. THE DELIVERY SHEATH WAS FOUND KINKED AT APPROXIMATELY 44 CM AND CURVED AT APPROXIMATELY 85 CM, WHEN MEASURED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. THE SHEATHING/UNSHEATHING TEST WAS NOT ABLE TO BE PERFORMED BECAUSE OF THE EXPOSED WIRE, KINKS, CURVES AND DRIED BLOOD INSIDE THE DELIVERY SHEATH. THE FILTER BAG WAS PULLED OUT BY HAND FOR EXAMINATION AND IT WAS OBSERVED TO BE IN GOOD CONDITION AND MET SPECIFICATIONS, NO ANOMALIES WERE OBSERVED. THE SLIT WAS PRESENT IN THE DELIVERY SHEATH AND MET SPECIFICATION. A PEEL AWAY TEST SUCCESSFULLY, 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 CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VASOSPASM OCCURRED. THE PATIENT PRESENTED WITH CEREBROVASCULAR DISORDER. THE STENOSED TARGET LESION WAS LOCATED IN AN ELONGATED, TORTUOUS RIGHT INTERNAL CAROTID ARTERY. A 3.5-5.5MM FILTERWIRE EZ WAS ADVANCED TO THE TARGET LESION BUT THE DELIVERY SHEATH COULD NOT BE SEPARATED FROM THE FILTER AND THE ENTIRE DEVICE WAS REMOVED. A SECOND 3.5-5.5 MM FILTERWIRE WAS INTRODUCED BUT ENCOUNTERED HIGH RESISTANCE, PARTLY DUE TO A VASOSPASM, AND WAS UNABLE TO ADVANCE. DURING INCREASED MANIPULATION OF THE FILTERWIRE, THE GUIDING SHEATH DISLOCATED INTO THE AORTIC ARCH AND HAD TO BE RETURNED TO THE DISTAL COMMON CAROTID ARTERY . THE DECISION WAS MADE TO COMPLETE THE PROCEDURE WITHOUT A FILTER WIRE. A NON-BSC GUIDE WIRE WAS INTRODUCED AND A NON-BSC STENT IMPLANTED WITH GOOD RESULT. THE PATIENT WAS RESTLESS DURING THE PROCEDURE BUT NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VASOSPASM OCCURRED. THE PATIENT PRESENTED WITH CEREBROVASCULAR DISORDER. THE STENOSED TARGET LESION WAS LOCATED IN AN ELONGATED, TORTUOUS RIGHT INTERNAL CAROTID ARTERY. A 3.5-5.5MM FILTERWIRE EZ WAS ADVANCED TO THE TARGET LESION BUT THE DELIVERY SHEATH COULD NOT BE SEPARATED FROM THE FILTER AND THE ENTIRE DEVICE WAS REMOVED. A SECOND 3.5-5.5 MM FILTERWIRE WAS INTRODUCED BUT ENCOUNTERED HIGH RESISTANCE, PARTLY DUE TO A VASOSPASM, AND WAS UNABLE TO ADVANCE. DURING INCREASED MANIPULATION OF THE FILTERWIRE, THE GUIDING SHEATH DISLOCATED INTO THE AORTIC ARCH AND HAD TO BE RETURNED TO THE DISTAL COMMON CAROTID ARTERY . THE DECISION WAS MADE TO COMPLETE THE PROCEDURE WITHOUT A FILTER WIRE. A NON-BSC GUIDE WIRE WAS INTRODUCED AND A NON-BSC STENT IMPLANTED WITH GOOD RESULT. THE PATIENT WAS RESTLESS DURING THE PROCEDURE BUT NO FURTHER COMPLICATIONS WERE 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 0015023843

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other SHEATH: 7F, COOK SHUTTLE 90CM| FILTERWIRE 3.5-5.5MM