BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXT DETACHMENT SYSTEM

    MDR report key: 652382 · Received November 18, 2005

    Report

    Report Number
    2029214-2005-00104
    Event Type
    Death
    Date Received
    November 18, 2005
    Date of Event
    November 4, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ANEURYSM COILING PROCEDURE, THAT THE LAST COIL WOULD NOT DETACH. IN ADDITION, THE CIRCUMSTANCES AROUND THE EVENT INDICATED THAT AFTER DEPLOYMENT OF THE FIRST COIL, THE ANEURYSM RUPTURED. THE PHYSICIAN ATTEMPTED TO STOP THE HEMORRHAGE WITH THE HYPERFORM BALLOON AND DEPLOYED 4 MORE COILS. HOWEVER, THE PT'S ARTERIAL BLOOD PRESSURE ROSE ABOVE 300MMHG AND A CARDIAC ARREST OCCURRED. AFTER ONE HOUR OF RESUSCITATION, THE PT EXPIRED. THE PHYSICIAN INDICATED THAT THE EVENT WAS NOT PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHMENT SYSTEM DETACHMENT SYSTEM HCG MICRO THERAPEUTICS, INC. NDS-1 562705

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death