BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 3910424 · Received July 2, 2014

    Report

    Report Number
    2029214-2014-00368
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION WITHOUT THE TENROU (B)(4) GUIDEWIRE. A PUNCTURE HOLE WAS FOUND AT APPROXIMATELY 5CM FROM THE DISTAL TIP; HOWEVER, THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT. CATHETER PUNCTURE. (B)(4).

    Description of Event or Problem · 1

    DURING THE TREATMENT OF THE BRAIN TUMOR, IT WAS REPORTED THE GUIDEWIRE (TENROU (B)(4)) HAD EXITED OUT OF THE CATHETER PRIOR TO THE DISTAL TIP DURING CATHETERIZATION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387893 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9836185

    Patients

    Seq Age Sex Outcome Treatment
    1