BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F-IDC - INTERLOCKING DETACHABLE COIL

    MDR report key: 1082063 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02056
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A GASTRO DUODENAL ARTERY PROCEDURE THAT AS THE PHYSICIAN WAS ADVANCING THE COIL TO THE AREA HE WANTED TO EMBOLIZE, HE REACHED A POINT WHERE HE WAS UNABLE TO ADVANCE ANY FURTHER. THE PHYSICIAN REPORTED HE THINKS THE LOCKING MECHANISM OF THE INTERLOCKING COIL "CAME UNDONE". THE PHYSICIAN PULLED OUT THE WIRE AND USED A COIL PUSHER TO RELEASE THE REST OF THE COIL. THE CASE WAS REPORTEDLY COMPLETED WITH THIS DEVICE. THE PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F-IDC - INTERLOCKING DETACHABLE COIL (84 HCG) INTERLOCKING DETACHABLE COIL HCG BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK