BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2480614 · Received March 6, 2012

    Report

    Report Number
    2029214-2012-00106
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 10, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EVALUATED. THE EVALUATION SHOWED THAT THE GUIDEWIRE BROKE INTO TWO SEGMENTS (DUE TO TORSION OVERLOAD) INSIDE THE CATHETER LUMEN AND ONE OF THE SEGMENTS PUNCTURED THE CATHETER LUMEN AT 1.5 CM FROM THE DISTAL TIP. CATHETER LUMEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN OPENING THE PACKAGE, A KINK WAS OBSERVED AT THE DISTAL END OF THE SYSTEM. THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4470 9519522

    Patients

    Seq Age Sex Outcome Treatment
    1