BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 1941620 · Received December 9, 2010

    Report

    Report Number
    2029214-2010-00260
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 12, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN EVALUATED. THE CATHETER TIP IS PARTIALLY SEPARATED AT THE POINT BETWEEN THE MARKER BAND AND THE END OF THE CATHETER BRAID. BASED ON THE INVESTIGATION, THE DAMAGE TO THE DISTAL TIP IS LIKELY TO HAVE OCCURRED AS A RESULT OF SHAPING THE TIP OF THE CATHETER PRIOR TO USE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER'S TIP ELONGATED AND BROKE OFF AFTER STEAM SHAPING FOR 30 SECONDS. THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON MICRO CATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 145-5092-150 7835001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK