BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC 1.5F

    MDR report key: 2488762 · Received March 12, 2012

    Report

    Report Number
    2029214-2012-00110
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 17, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 27.3 CM FROM THE DISTAL TIP. THE CATHETER APPEARS TO HAVE RUPTURED DURING ANGIOGRAPHIC INJECTION DUE TO OVER-PRESSURIZATION AS A RESULT OF AN UNDETECTED KINK OR OTHER OBSTRUCTION OF THE CATHETER AND THIS WAS NOT DETECTED UNTIL ONYX INJECTION. CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THAT ONYX WAS OBSERVED COMING OUT FROM THE GUIDE CATHETER DURING ONYX INJECTION. THE DELIVERY CATHETER WAS REMOVED FROM THE PATIENT AND FOUND RUPTURED. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2012-00111.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5066 9519016

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability