BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICROCATHETER

    MDR report key: 4112832 · Received September 17, 2014

    Report

    Report Number
    2029214-2014-00546
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION AND THE PROXIMAL MARKER BAND WAS FOUND TO BE CRUSHED. THE CATHETER WAS FOUND LEAKING AT THE DISTAL PART OF THE HUB; HOWEVER, THE CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER SHOWED NO QUALITY ISSUES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE, IT WAS REPORTED THE ECHELON CATHETER WAS FOUND TO BE LEAKING AT THE THIRD OF THE LENGTH OF THE CATHETER AS THE PHYSICIAN WAS FLUSHING IT WITH A 1ML SYRINGE FOR PREPARATION. A NEW MICROCATHETER WAS TESTED AND USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577044 ECHELON MICROCATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 105-5091-150 9763721

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR