BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC 1.5F

    MDR report key: 1852397 · Received September 28, 2010

    Report

    Report Number
    2029214-2010-00209
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS LEFT IN THE PT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED DURING PROCEDURE, THE CATHETER BECAME ENTRAPPED INTO THE ONYX IN THE PCA ARTERY. AFTER SEVERAL ATTEMPTS TO RETRIEVE THE CATHETER, THE PHYSICIAN DECIDED TO LEAVE THE CATHETER IN THE PT UNTIL THE SURGICAL RESECTION THAT WAS SCHEDULED LATER IN THE WEEK. DURING SURGICAL RESECTION, THE AVM AND CATHETER WERE REMOVED. APPROX 15 CM OF THE CATHETER WAS REPORTED LEFT IN THE PT. SAME EVENT AS MDR# 2029214-2010-00210.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention| S