BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2493269 · Received March 15, 2012

    Report

    Report Number
    2029214-2012-00146
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 19, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED WITH THE GUIDEWIRE. THE EVALUATION SHOWED THAT THE CATHETER WAS PUNCTURED AT 1.4CM FROM THE DISTAL TIP AND THE GUIDEWIRE WAS BROKEN IN TWO SEGMENTS DUE TO TORSIONAL OVERLOAD. CATHETER LUMEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INSERTION THE BALLOON CATHETER THROUGH THE GUIDE CATHETER, RESISTANCE WAS ENCOUNTERED. UPON REMOVAL, THE BALLOON CATHETER WAS FOUND TORN AT THE DISTAL SECTION.NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4470 9516564

    Patients

    Seq Age Sex Outcome Treatment
    1