BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXT DETACHABLE COIL, TENSION SAFE

    MDR report key: 607588 · Received May 26, 2005

    Report

    Report Number
    2029214-2005-00035
    Event Type
    Injury
    Date Received
    May 26, 2005
    Date of Event
    March 11, 2005
    Report Date
    May 26, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SAH ANEURYSM COILING (MALE GRADE IV-BASILAR TIP 6MM. PHYSICIAN ACCESSED LESION WITH ECHELON 14 MICRO CATHETER AND SYNCHRO 14 GUIDEWIRE. PHYSICIAN DEPLOYED 6 MTI NXT COILS SUCCESSFULLY INTO LESION AND CHOSE N-2-2-T10-TS AS 7TH COIL. COIL ENTERED ANCURYSM COILING MASS AND PROCEED TO PERFORATE THE FUNDUS OF THE ANEURYSM. COIL WAS PULLED BACK AND MICRO CATHETER RUN SHOWED DEFINITE CONTRAST EXTRAVASATION. COIL WAS DEPLOYED AGAIN AND DETACHED SUCCESSFULLY ALONG WITH AN 8TH COIL N-S-1-T10-TS. FOLLOW-UP CT SCAN SHOWED CONTRAST IN THE 3RD VENTRICLE BUT DID NOT SHOW ANY BLOOD IN THE VENTRICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHABLE COIL, TENSION SAFE ELECTROLYTICALLY DETACHABLE COIL. HCG MICRO THERAPEUTICS, INC. N-2-2-T10-TS 1097578

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening