BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 1021179 · Received March 28, 2008

    Report

    Report Number
    1058196-2008-00088
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    October 22, 2007
    Report Date
    February 29, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETED. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE COIL STRETCHED/SEPARATED IN PT. THIS PT WAS UNDERGOING COIL EMBOLIZATION WITHIN THE BASILAR TIP ANEURYSM MEASURING 14MM X 12MM X 11MM. NO CALCIFICATION AND MINIMAL TORTUOSITY WAS PRESENT WITHIN THE VESSEL. SEVEN COILS WERE PLACED USING THE PROWLER SELECT PLUS 606-S255X MICROCATHETER WITHOUT DIFFICULTY. NO RESISTANCE FELT WHILE ADVANCING THE 8TH COIL INTO THE MICROCATHETER. THE COIL WAS BEING WITHDRAWN FOR REPOSITIONING IN THE ANEURYSM WHEN STRETCHED AND WAS HALF IN THE ANEURYSM AND HALF IN THE MICROCATHETER. THERE WAS ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE VERIFIED WITH FLUORO PRIOR TO REPOSITIONING. CONTINUOUS FLUSH WAS MAINTAINED WITHIN THE MICROCATHETER. THE COIL WAS STRETCHED ALL THE WAY TO THE GROIN. AT THIS TIME, IT WAS FELT THAT THE COIL WOULD INCORPORATE ITSELF INTO THE WALL OF THE VESSEL, CAUSING THE PT NO HARM. THE PT WILL REMAIN ON PLAVIX FOR THREE MONTHS..ASA FOR LIFE. THERE WAS ADVERSE EFFECT TO THE PT. THERE WAS NO RESISTANCE BETWEEN THE GW AND THE MC WHEN ACCESSING THE TARGET SITE. PRODUCT WILL BE RETURNED FOR ANALYSIS. THE SECTION OF STRETCHED COIL THEY WERE ABLE TO REMOVE. THE DISTAL PART OF THE COIL IS IN THE ANEURYSM AND STRETCHED DOWN THE BASILAR ALL THE WAY TO THE GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 13320306

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention COILS & MC