BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUVILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1584629 · Received January 20, 2010

    Report

    Report Number
    1058196-2010-00026
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    September 25, 2009
    Report Date
    December 25, 2009
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVAL AND TESTING; HOWEVER, THE ENGINEERING EVAL IS NOT COMPLETE. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT REC'D FROM THE AFFILIATE INDICATED THAT DURING AN INTERVENTIONAL NEUROVASCULAR PROCEDURE FOR COIL EMBOLIZATION, AFTER SUCCESSFUL PLACEMENT OF TWO COILS THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITION OF THE TRUFILL DCS ORBIT MINI COMPLEX FILL 2 X 1.5 COIL. THE PHYSICIAN THEN TRIED TO WITHDRAW THE COIL BACK INTO THE MICROCATHETER UNSUCCESSFULLY. ANOTHER 2 X 1.5 COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE TARGET LESION WAS AN ANEURYSM OF THE ANTERIOR CEREBRAL ARTERY. ACCESS FOR THE PROCEDURE WAS FEMORAL. A 5 FR GUIDING CATHETER, AN EV3 MICRO-WIRE, AND A PROWLER 14 MICROCATHETER WERE POSITIONED PROPERLY. THERE WAS NO REPORTED PT INJURY OR LOSS OF ACCESS TO THE TARGET LESION. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUVILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 13427498

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR PROWLER 14 MICROCATHETER| 5 FR GUIDING CATHETER| EV3 MICRO GUIDEWIRE