BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1984133 · Received February 10, 2011

    Report

    Report Number
    2029214-2011-00031
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 12, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN PROXIMAL PORTION OF THE CATHETER WAS RETURNED WITH APPROXIMATELY 21.6 CM OF THE DISTAL TIP MISSING. EVALUATION CONFIRMED THAT THE CATHETER WAS BROKEN DUE TO EXCESSIVE TENSILE FORCES APPLIED DURING USE. (B)(4)

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THE CATHETER BROKE OFF DURING REMOVAL. THE BROKEN SEGMENT WAS REPORTED REMAINING IN THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5055 9336465

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability