BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERSPEED HYDROPHILIC GUIDEWIRE

    MDR report key: 3770108 · Received April 24, 2014

    Report

    Report Number
    2029214-2014-00238
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SILVERSPEED GUIDEWIRE WAS RETURNED FOR EVALUATION STUCK INSIDE THE ULTRAFLOW CATHETER AND A PUNCTURE HOLE WAS FOUND AT APPROXIMATELY 2.5CM FROM THE DISTAL TIP. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT. RESULTS: GUIDEWIRE PUNCTURED CATHETER. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A WIDE DISTAL AVM (ARTERIOVENOUS MALFORMATION) IN THE ARTERIAL TEMPORALIS SUPERFICIALIS. ON (B)(6) 2014, THE PATIENT UNDERWENT EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE SILVERSPEED GUIDEWIRE PUNCTURED THE ULTRAFLOW CATHETER. THE GUIDEWIRE AND CATHETER WERE BOTH REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249081 SILVERSPEED HYDROPHILIC GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR 103-0601-200 9793499

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR