BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2071877 · Received April 28, 2011

    Report

    Report Number
    2029214-2011-00088
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSWIRE WAS RECEIVED IN TWO BROKEN SEGMENTS. ANALYSIS OF THE BREAK POINT SHOWED THE FAILURE OF THE PUSHWIRE OCCURRED DUE TO TORSIONAL OVERLOAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIPELINE WAS IMPLANTED. WHILE REMOVING THE PUSHWIRE, THE DISTAL SECTION SEPARATED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN SEGMENT WITH AN ALLIGATOR. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE EMBOLIZATION DEVICE HCG EV3 NEUROVASCULAR FA-77400-20 9328771

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention