BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO 14 NEURO GUIDEWIRE

    MDR report key: 885689 · Received July 24, 2007

    Report

    Report Number
    6000078-2007-00204
    Event Type
    Injury
    Date Received
    July 24, 2007
    Date of Event
    June 29, 2007
    Report Date
    June 29, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510 (K): K023700, K002907.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007, A TRANS-ARTERIAL EMBOLIZATION PROCEDURE OF THE HEPATIC ARTERY. DURING THE PROCEDURE, THE DISTAL TIP OF THE GUIDEWIRE (SUBJECT DEVICE) FRACTURED. "THE FRACTURED WIRE WAS SUCCESSFULLY REMOVED WITH A SNARE." THE PT SUFFERED NO COMPLICATIONS FROM THIS EVENT, AND IS REPORTED TO BE IN GOOD CONDITION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 14 NEURO GUIDEWIRE DQX- GUIDEWIRE DQX NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 1301 B09893

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention PARKWAY MICROCATHETER (UNK MFG)| THERAPY