BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1915591 · Received December 6, 2010

    Report

    Report Number
    2134265-2010-05449
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DISTAL TIP OF THE PROTECTION WIRE WAS CURLED AND STRETCHED APPROXIMATELY 6 MM ON ITS PROXIMAL PORTION. THE FILTER BAG OF THE PROTECTION WIRE WAS COMPLETELY DEPLOYED FROM THE DELIVERY SHEATH. DRIED BLOOD AND PARTICLE WAS SEEN INSIDE THE FILTER BAG. DRIED BLOOD WAS ALSO PRESENT INSIDE THE DELIVERY SHEATH. THE PROTECTION WIRE WAS POPPING OUT OF THE DELIVERY SHEATH FROM 6.8 CM TO 10.8 CM MEASURED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. THE DELIVERY SHEATH WAS KINKED AT APPROXIMATELY 60.0 CM AND 125.5 CM MEASURED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. THE DELIVERY SHEATH BROKE OFF (SEPARATED) APPROXIMATELY 96.5 CM MEASURED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. THE DELIVERY SHEATH WAS NOT STRETCHED NEAR OR WITHIN THE BROKEN LOCATION. THE DELIVERY SHEATH WAS PARTIALLY PEELED AWAY APPROXIMATELY 13.5 CM MEASURED FROM THE EXIT PORT OF THE DELIVERY SHEATH. THE PROTECTION WIRE WAS KINKED AT APPROXIMATELY 120.2 CM MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE INTRODUCER SHEATH SEPARATED. THE FILTERWIRE EZ WAS ADVANCED DISTAL TO THE TARGET LESION, FOR CORONARY BYPASS GRAFT PROTECTION. WHEN THE PHYSICIAN WAS DEPLOYING THE FILTERWIRE EZ, RESISTANCE WAS NOTED. WHILE REMOVING THE INTRODUCER SHEATH, THE PHYSICIAN RECOGNIZED THAT 70CM OF THE DISTAL PORTION OF THE SHEATH WAS STILL ON THE FILTERWIRE EZ INSIDE THE PATIENT AND THE OTHER PORTION WAS OUTSIDE THE PATIENT. HE THEN CAREFULLY REMOVED THE FILTERWIRE EZ OUT OF THE PATIENT IN AN OPEN STATE WITH THE DISTAL PORTION OF THE SHEATH STILL ON THE WIRE. THE THROMBUS WAS CAUGHT IN THE FILTERWIRE EZ BASKET DURING THIS MANEUVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT 0.014 NON BSC GUIDEWIRE AND A 3.5MM NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE INTRODUCER SHEATH SEPARATED. THE FILTERWIRE EZ WAS ADVANCED DISTAL TO THE TARGET LESION, FOR CORONARY BYPASS GRAFT PROTECTION. WHEN THE PHYSICIAN WAS DEPLOYING THE FILTERWIRE EZ, RESISTANCE WAS NOTED. WHILE REMOVING THE INTRODUCER SHEATH, THE PHYSICIAN RECOGNIZED THAT 70CM OF THE DISTAL PORTION OF THE SHEATH WAS STILL ON THE FILTERWIRE EZ INSIDE THE PATIENT AND THE OTHER PORTION WAS OUTSIDE THE PATIENT. HE THEN CAREFULLY REMOVED THE FILTERWIRE EZ OUT OF THE PATIENT IN AN OPEN STATE WITH THE DISTAL PORTION OF THE SHEATH STILL ON THE WIRE. THE THROMBUS WAS CAUGHT IN THE FILTERWIRE EZ BASKET DURING THIS MANUEVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT 0.014 NON BSC GUIDEWIRE AND A 3.5MM NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    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 0013412571

    Patients

    Seq Age Sex Outcome Treatment
    1 Other