BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1117866 · Received August 13, 2008

    Report

    Report Number
    1058196-2008-00196
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 23, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1058196-2008-001966 AND 1058196-2008-00197.

    Description of Event or Problem · 1

    THE PHYSICIAN POSITIONED THE COIL IN THE LESION BUT FELT PLACEMENT WAS NOT PRECISE. THEREFORE, HE PULLED THE COIL BACK INTO THE MICROCATHETER (RENEGADE, BSJ) AND ATTEMPTED TO DETACH THE COIL A SECOND TIME. AT THIS TIME, FRICTION WAS FELT AT THE DISTAL END OF THE MC AND THE COIL COULD NOT BE PUSHED OR PULLED ANY FURTHER. THE COIL AND THE MC WERE REMOVED AS ONE UNIT FROM THE PT. THE SAME MC WAS RE-INSERTED AND A SECOND COIL WAS ADVANCED. THERE WAS ALSO FRICTION WITH THIS COIL AND THE COIL BECAME STUCK IN THE MC. IT WAS NOTICED THAT THE COIL HAD ALSO BEEN STRETCHED DURING DELIVERY. THE COIL WAS WITHDRAWN FROM PT, WITHOUT DIFFICULTY, STILL ATTACHED TO THE DELIVERY SYSTEM. THE PT IS A MALE (AGE UNK). THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY (SIDE UNK). THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY PRESENT. THE RATE OF STENOSIS WAS 95%. THERE WAS AN ADEQUATE CONTINUOUS FLUSH MAINTAINED THROUGHOUT THE MC DURING THE PROCEDURE. THERE IS NO INFO AS TO IF THERE WAS ANY DIFFICULTY INSERTING THE MC INTO THE TARGET LESION THE RESISTANCE WAS FELT WHILE PUSHING THE COIL THROUGH THE MC. THERE WERE NO OTHER COILS INSERTED THROUGH THE MC PRIOR TO THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH IDC (BOSTON SCIENTIFIC) COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 13397554

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MICROCATHETER (RENEGADE