BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULRAFLOW HPC 1.5F

    MDR report key: 3910581 · Received July 2, 2014

    Report

    Report Number
    2029214-2014-00376
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ULTRAFLOW CATHETER WAS RETURNED FOR EVALUATION AND IT WAS FOUND RUPTURED AT APPROXIMATELY 25CM FROM THE DISTAL TIP. THE APPEARANCE OF THE RUPTURE IS CONSISTENT WITH OVER-PRESSURIZATION AS A RESULT OF AN UNDETECTED KINK OR OTHER OBSTRUCTION OF THE CATHETER, RESULTING IN PRESSURES EXCEEDING THE LIMITS OF THE CATHETER. CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION). ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. IT WAS REPORTED DURING ONYX INJECTION, RESISTANCE WAS ENCOUNTERED AND THE CATHETER WAS REMOVED FROM THE PATIENT. ON THE BACK TABLE, THE CATHETER WAS TESTED WITH HIGH PRESSURE AND IT WAS FOUND TO BE LEAKING AT THE FLEXIBLE DISTAL SECTION. A NEW ULTRAFLOW CATHETER WAS USED WITH THE SAME GUIDEWIRE AND ONYX TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2014-00377.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388123 ULRAFLOW HPC 1.5F FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5065 9867692

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR