BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HPYERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 710198 · Received May 9, 2006

    Report

    Report Number
    2029214-2006-00055
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    April 3, 2006
    Report Date
    April 10, 2006
    Manufacturer
    EV3 NEUROVASCULAR DIVISION
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LEFT PGM ANEURYSM TREATMENT PROCEDURE, IT WAS RPEORTED PHYSICIAN EXPERIENCED DIFFICULTY IN BALLOON DEFLATION. WHEN EXAMINED AFTER PROCEUDRE, THE DISTAL SHAFT HAS BEEN FOUND DAMAGED AND INFLATED NO COMPLICATIONS WERE REPORTED TO HAVE OCCURRED WITH THE OT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HPYERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN EV3 NEUROVASCULAR DIVISION 104-4127 1436080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN