BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MICRO CATHETERS

    MDR report key: 4840795 · Received June 12, 2015

    Report

    Report Number
    2029214-2015-00660
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    March 1, 2010
    Report Date
    May 14, 2015
    Manufacturer
    IRVINE
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS CREATED TO CAPTURE THE EVENT RELATED TO THE UNKNOWN MICROCATHETER. THE CATHETER WAS NOT RETURNED FOR ANALYSIS; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED, AND THE EVENT CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. PER THE ONYX IFU (INSTRUCTIONS FOR USE): DO NOT ALLOW MORE THAN 1 CM OF ONYX LES TO REFLUX BACK OVER CATHETER TIP. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFR: 2029214-2015-00659; 2029214-2015-00661. (B)(4.

    Description of Event or Problem · 1

    CITATION: XIANLI LV, ET AL. EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS WITH ONYX-18. EUROPEAN JOURNAL OF RADIOLOGY 73 (2010) 66-671 VOLUME 73, ISSUE 3, MARCH 2010. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: ONE MICROCATHETER BECAME STUCK DURING EMBOLIZATION. THE MARATHON OR ECHELON 10 MICROCATHETERS WERE USED FOR THE EMBOLIZATION PROCEDURE. IT IS UNKNOWN WHICH OF THE TWO CATHETERS WAS INVOLVED IN THE CATHETER ENTRAPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386270 UNKNOWN MICRO CATHETERS CATHETER, CONTINUOUS FLUSH KRA IRVINE UNKNOWN MICRO CATHETERS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR