BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1823517 · Received September 2, 2010

    Report

    Report Number
    2134265-2010-04121
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE PROTECTION WIRE, DELIVERY SHEATH, AND RETRIEVAL SHEATH WERE RETURNED FOR ANALYSIS INSERTED THROUGH A NON-BSC HEMOSTASIS VALVE. THE DELIVERY SHEATH WAS STILL PRESENT, AND WAS NOT REMOVED FROM THE PROTECTION WIRE. THE RETRIEVAL SHEATH WAS INSERTED OVER THE PROTECTION WIRE AND WAS STUCK INSIDE OF THE VALVE. THE DISTAL TIP OF THE PROTECTION WIRE WAS WAVY AND STRETCHED APPROXIMATELY 7.0MM ON ITS PROXIMAL PORTION. THE PROTECTION WIRE WAS WAVY AND KINKED AT APPROXIMATELY 135.5CM MEASURED FROM THE PROXIMAL END. THE NOSECONE WAS EXPOSED APPROXIMATELY 5.0MM MEASURED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. THE PROTECTION WIRE WAS BROKEN AT APPROXIMATELY 13CM MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE FILTERWIRE COMPONENTS WERE REMOVED FROM THE HEMOSTASIS VALVE AND THE REMAINING PART OF THE PROTECTION WIRE THAT BROKE OFF WAS STILL ATTACHED INSIDE OF THE RETRIEVAL SHEATH. THE DISTAL END OF THE RETRIEVAL SHEATH WAS FLATTENED AND DEFORMED. THE DELIVERY SHEATH WAS STRETCHED FROM 6.6CM TO 13.9CM, FROM 18.2CM TO 37.0CM, AND FROM 108.6CM TO 110.5CM RESPECTIVELY, MEASURED FROM THE DISTAL TIP OF THE DELIVERY SHEATH. IN ADDITION THE DELIVERY SHEATH MEASURED 121CM; APPROXIMATELY 30.4CM OF THE PROXIMAL PORTION OF THE DELIVERY SHEATH WAS MISSING AND WAS NOT RETURNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS DETERMINED TO BE USER RELATED AS THE DFU WAS NOT FOLLOWED. PRODUCT ANALYSIS FOUND THAT THE USER ATTEMPTED TO RETRIEVE THE FILTER WITH THE RETRIEVAL SHEATH, BEFORE REMOVING THE PROXIMAL PORTION OF THE DELIVERY SHEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY REMODEL TREATMENT PROCEDURE, A FILTERWIRE BROKE. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A 95% STENOSED, 17MM IN LENGTH, ECCENTRIC SHAPED, DE-NOVO LESION LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED, 5MM IN DIAMETER, RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS NOT PRE-DILATED. THIS 190CM FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM WAS ADVANCED INTO POSITION AGAINST RESISTANCE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE FILTER, HOWEVER, "STRONG" RESISTANCE WAS ENCOUNTERED BETWEEN THE PROTECTION WIRE AND THE DELIVERY SHEATH. THE PHYSICIAN FOUND IT DIFFICULT TO PULL BACK THE DELIVERY SHEATH. AFTER MANY ATTEMPTS AT DEPLOYING THE FILTER, THE PROTECTION WIRE BROKE INTO TWO PIECES NEXT TO THE "PORT OF INTRODUCER SHEATH". THE DEVICE WAS "RETRIEVED FULLY" AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY REMODEL TREATMENT PROCEDURE, A FILTERWIRE BROKE. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A 95% STENOSED, 17MM IN LENGTH, ECCENTRIC SHAPED, DE-NOVO LESION LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED, 5MM IN DIAMETER, RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS NOT PRE-DILATED. THIS 190CM FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM WAS ADVANCED INTO POSITION AGAINST RESISTANCE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE FILTER, HOWEVER, "STRONG" RESISTANCE WAS ENCOUNTERED BETWEEN THE PROTECTION WIRE AND THE DELIVERY SHEATH. THE PHYSICIAN FOUND IT DIFFICULT TO PULL BACK THE DELIVERY SHEATH. AFTER MANY ATTEMPTS AT DEPLOYING THE FILTER, THE PROTECTION WIRE BROKE INTO TWO PIECES NEXT TO THE "PORT OF INTRODUCER SHEATH". THE DEVICE WAS "RETRIEVED FULLY" AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 0000931601

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: 8F MACH1