BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYPERFARM OCCLUSION BALLOON SYSTEM

    MDR report key: 478833 · Received August 20, 2003

    Report

    Report Number
    2029214-2003-00032
    Event Type
    Death
    Date Received
    August 20, 2003
    Date of Event
    July 21, 2003
    Report Date
    July 21, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS FOR EMBOLIC COILING OF AN ANEURYSM. THE BALLOON INFLATED/DEFLATED NORMALLY DURING PREPARATION. THE BALLOON WAS PREPPED WITH SALINE. WHEN INFLATED DURING THE PROCEDURE, THE BALLOON WAS NOT VISIBLE. THE PROCEDURE WAS CONTINUED. THE CATHETER WAS MOVED DISTAL TO THE ANEURYSM. THE PHYSICIAN FLUSHED THROUGH THE CATHETER AFTER REMOVING THE GUIDEWIRE. AN EXCHANGE GUIDEWIRE WAS PLACED. THE SYSTEM WAS PULLED BACK APPROXIMATELY 10CM PROXIMAL TO THE ANEURYSM. THE PATIENT MOVED. THE PATIENT'S PRESSURE CHANGED AND THEY BECAME AWARE THAT THE ANEURYSM RUPTURED, AS THE PHYSICIAN THOUGHT THAT THE BALLOON MIGHT STILL BE PARTIALLY INFLATED, ADDITONAL DEFLATION WAS ATTEMPTED. THE CATHETER WAS WITHDRAWN QUICKLY, AND THE CATHETER BROKE IN THE INTRODUCER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFARM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN MICRO THERAPEUTICS, INC. 104-4470 72511

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death EMBOLIC COILS, EXCELSIOR SL-10 MICRO CATHETER,| X-PEDION GUIDEWIRE, X-CELERATOR EXCHANGE GUIDEWIRE