BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2972370 · Received February 21, 2013

    Report

    Report Number
    2029214-2013-00136
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MARKSMAN CATHETER, PUSHWIRES, AND PIPELINES WERE RETURNED FOR EVALUATION. THE PIPELINES WERE FOUND ALREADY OPENED AND RELEASED FROM THEIR CAPTURE COILS; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT HAVE NOT BEEN RETURNED FOR EVALUATION.THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS:MODEL: FA-77450-12 / LOT: 9612510 / DOM: 07/16/2012 / EXP: 05/16/2014. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT TWO PIPELINES WOULD NOT RELEASE FROM THEIR CAPTURE COILS SO THEY WERE CORKED AND REMOVED FROM THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76642 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-14 9674061

    Patients

    Seq Age Sex Outcome Treatment
    1