BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2371416 · Received September 29, 2011

    Report

    Report Number
    2029214-2011-00276
    Event Type
    Malfunction
    Date Received
    September 29, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 30, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDEWIRE WAS RETURNED WITH APPROX 10 CM OF THE DISTAL TIP MISSING. ANALYSIS OF THE BREAK POINT SHOWED THE FAILURE OF THE CORE WIRE OCCURRED DUE TO FATIGUE TORSIONAL OVERLOAD. THE BALLOON CATHETER WAS ALSO RETURNED AND FOUND RUPTURED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDEWIRE (PROVIDED WITH THE BALLOON SYSTEM) BROKE INSIDE THE BALLOON CATHETER DURING PROCEDURE. THE ENTIRE SYSTEM WAS REMOVED FROM THE TP AND THE PROCEDURE CONTINUED WITH A NEW SYSTEM. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON, NUF NUF EV3 NEUROVASCULAR 104-4470 9449519

    Patients

    Seq Age Sex Outcome Treatment
    1